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With so many opportunities within the generics industry today as patents expire, new companies are entering the generics market and established companies are adding to their portfolios. This paper looks at the role of branding as generics look to compete more vigorously in this highly competitive arena, and the challenges that exist in creating brand identities to drive their marketing. The overall competitive marketplace has changed considerably over time and created a very different context in respect of customer 'need' states. There is an increasing need to address the end consumer directly via focus on brands. There is continuing proof that adding consumer benefits via effective brand communication can contribute enormously to commercial success - and this is examined here. Generics companies marketing generic products should recognise the benefits of creating brands to achieve visibility, stand-out and clear differentiation via a consumer focused proposition - and the role that brand identity can play within this. [ABSTRACT FROM AUTHOR]

Objective: Product life cycle (PLC) refers to the time ranging from when a product is introduced into the market until it is taken off the shelves. Product life cycle management can guarantee product survival and prevent it from declining. The purpose of this study is to explore factors influencing the life cycle of generic pharmaceutical product and their effect sizes to shed light on better approaches for the life cycle management of such products. Method: To this end, a standard questionnaire containing six dimensions and 47 items was used to collect data from 302 industrial pharmacists. The research hypotheses were tested using structural equation modeling to quantify the relationship between each dimension and its associated factors with the PLC. Key finding: The results indicated that government interventions (Standard estimate (SE) = 0.63) and technology advancement (SE = 0.60) as environmental factors, quality (SE = 0.60) and price (SE = 0.62) satisfaction, patient adherence (SE = 0.68), physicians' awareness (SE = 0.64), market saturation (SE = 0.60); and demand rate (SE = 0.62) as demand factors, brand power (SE = 0.92); and availability of imported competitors (SE = 0.59) as competition factors, drug safety (SE = 0.63), product appearance (SE = 0.57); and ease of administration (SE = 0.61) as product-related factors, manufacturer reputation (SE = 0.63); and production continuity (SE = 0.64) as producer-related factors, and distributors number (SE = 0.54); and on-time delivery and availability of products (SE = 0.69) as distributor-related factors at 5% significance levels had the most effect on generic pharmaceutical PLC in Iran. Conclusion: For the first time, this study offers a structural equation modeling framework for better managing the PLC of generic pharmaceutical products to help the company's performance and survival. [ABSTRACT FROM AUTHOR]

The regulatory agencies all over the world have defined the pathway and the regulations for approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for approval of biosimilar. According to this viewpoint, the approval of complex generics, also known as non-biological complex pharmaceuticals, is not subject to any clearly defined regulations (NBCDs). Although they differ from biologic products, complex medicines are constructed of huge, extremely complex, and synthetic components. The regulatory frameworks that are currently being used for complicated generics are opaque and uncertain. The market for complex generics is huge and there are fewer generic competitors in this area. In addition, the cost of bringing such generics into the market is high. Thus, there is a need for a well-defined pathway and guidance documents for the authorization of generic versions of complex drug products. The paper focus on the regulatory frameworks that the USA, EU, and Latin America have developed at this time to allow for the introduction of complicated generics to the market. In order to analyse regulatory policies in the USA, Europe, and Latin America for the marketing of NBCD copies, a case study of a product with an approved generic version is used. It also describes on the regulatory disparities existing among the three agencies in the light of complex generics. [ABSTRACT FROM AUTHOR]

Aim: To analyze drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria by using quantitative and qualitative parameters at national level. To assess generic penetration as a part of rational drug use. Materials and methods: Design: retrospective study of publicly accessible data from registries of National health insurance fund for the period January–December 2017. The analyses are in accordance with ATC/DDD methodology of WHO. The data was processed via descriptive statistical methods. Results: The analyzed population includes 185 671 patients with essential arterial hypertension—13.33% of all hypertensive patients. The expenses for 2017 are 9 796 940.12 BGN (Bulgarian leva; 1 Euro=1.95,585 BGN). The expense per patient per year is 52.76 BGN, monthly expense is 4.40 BGN and daily expense is 0.14 BGN. The sum of 9 796 940.12 BGN is divided into two groups—expenses for monoproducts 65.88% and expenses for combined products 34.12%. Blockbusters are INNs lercanidipine and nebivolol. The total expenses for uncomplicated essential arterial hypertension are 1.22% of the total expenses. With this resource, 1.6 DDD/Patient/Day is provided. Discussion: In Bulgarian therapeutic practice, the most prescribed products are beta-blockers nebivolol and bisoprolol, calcium antagonist lercanidipine, and centrally acting antiadrenergic agents rilmenidine and moxonidine. Sartanes are represented mainly by valsartan. In all section analyses, the considerable use of lercanidipine is evident. Reference (original) medicinal products are mainly prescribed, while the market share of generic products, both in terms of costs and DDD, is significantly lower. Obtained results are inconsistent with European recommendation, while lack of national pharmacotherapeutic guideline poses a serious challenge. [ABSTRACT FROM AUTHOR]

Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct. [ABSTRACT FROM AUTHOR]

Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator's product, and hence can be substituted in clinical practice. The Gulf Cooperation Council's pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council's. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure. [ABSTRACT FROM AUTHOR]

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays. [ABSTRACT FROM AUTHOR]

This case provides useful guidance to generic companies launching a product with a skinny label, where patented indications have been carved out. Warner-Lambert obtained an order for NHS England to cascade prescribing guidance to enable prescribers and pharmacists to avoid patent infringement, but also to remove any objections to the generic launch. This demonstrates that the utility of a second medical use patent in preventing generic entry may be rather limited. [ABSTRACT FROM AUTHOR]

This study was undertaken to determine the type and extent of deficiencies in generic product dossiers in the therapeutic areas of HIV/AIDS, tuberculosis, malaria and reproductive health, as submitted to the WHO Prequalification of Medicines Programme. There were considerably more quality-related deficiencies in tuberculosis, malaria and reproductive health dossiers compared to HIV dossiers, especially in the category specification of active pharmaceutical ingredients, development pharmaceutics, manufacturing method and finished pharmaceutical product specifications. The deficiencies related to the efficacy/safety portion of the dossiers displayed a trend similar to that observed in the quality portion in that the most critical deficiencies such as an incorrect study design, the use of an unacceptable comparator or the failure to include a study occurred considerably more frequently in the tuberculosis, malaria and reproductive health dossiers than in the HIV dossiers. The frequency of dossier-related deficiencies as determined on screening and assessment of the dossiers seemed to be inversely related to the number of product dossiers that had been prequalified by the end of 2010. The results of this study stress the need for continued capacity building of local generic manufacturers, further development of pharmacopoeial monographs by WHO (PhInt) and other pharmacopoeial commissions, not least to promote development of generic products, as well as development of new guidelines (WHO guidelines for development of generic and paediatric products and a technology transfer guidance document are currently being finalized). To our knowledge, this is the first comprehensive review of the quality and efficacy/safety portions of generic product dossiers, originating from pharmaceutical companies in emerging markets, and comparison of dossier deficiencies across four critically important therapeutic areas. [ABSTRACT FROM AUTHOR]

Generic medicines play a key role in the affordability of pharmaceuticals. This study aims to compare price and to document the actual savings that can be achieved if generics are used by consumers in the state of Penang, Malaysia. This is a cross-sectional pilot study on the price of innovator and generic medicines for the 20 most-used medications in Malaysia. Upon consent, 20 retail pharmacies were conveniently selected. A pre-validated data collection form was used to collect their selling price from the community pharmacist. The analysis was limited to medicines in the same dosage form and dose. Those still under patent protection or combined with other active ingredients were excluded from the study. This study found that most innovator drugs are 27–90 per cent more expensive than generics. Some generic drugs are, however, more expensive than their innovator counterparts (40 per cent higher). Some locally produced generics are also more expensive than foreign products. The current findings suggest that consumers can save up to 90 per cent of the cost of their medication by using generic products. Further investigation is needed to explore the causality of the observed differences in price of products in order to increase their accessibility to the general population.Journal of Generic Medicines (2008) 6, 35–42. doi:10.1057/jgm.2008.25; published online 21 October 2008 [ABSTRACT FROM AUTHOR]

Generic products are cost effective and speedy surrogates for high-priced innovator/branded products. The prerequisite for the development of a generic product is therapeutic equivalence (comprising pharmaceutical equivalence and bioequivalence) to the innovator product, thus ensuring comparable efficacy and safety profile. The probability of successfully developing a bioequivalent product can be improved by developing a formulation equivalent to the reference listed drug (RLD), in terms of the quantitative, solid-state characteristics of the active pharmaceutical ingredient (API) and the manufacturing process. This can be achieved by a systematic and thorough characterisation of the RLD. The present study was aimed at developing a methodology for characterisation of ranitidine hydrochloride tablets, with special emphasis on the solid-state characterisation of the API in the tablet. A differential solubility method was employed for the separation and quantification of excipients present in the tablet. Solid-state properties were characterised using a range of microscopic, thermal, spectroscopic and crystallographic techniques. In addition, results were confirmed by preparing inhouse tablets of the polymorphic forms I and II, using the decoded quantitative formula. [ABSTRACT FROM AUTHOR]

Health is the prime component for every person, and in the world, there are different traditions that have their own approaches to treat and cure illness. The dosage form of the drug may appear different but medically, however, a genericmedicament has the samemechanism in the body as that of the costlier brand-name drugs. They acquire the equal active ingredient an have the identical quality asd must pass the same satisfactory standards with respect to manufacturing and packaging of medicaments. The generic medicinal drug beneath the regulation of U.S. Food and Drug Administration must have the equal quality and performance as that of the brand-name drugs. The Food and Drug Administration states: 'Generics have the identical quality as brand identify drugs'. When a generic drug product is approved, it has met rigorous standards established via the Food and Drug Administration with respect to identity, strength, quality, purity and potency. India started Jan Aushadhi scheme to make quality medicines handy to the shoppers at affordable prices. Given the socioeconomic conditions and the level of ignorance and illiteracy with vast disparities of income in the country, the advantage of the scheme can be taken by the consumers or should reach the consumers particularly the poor and the needy, only when a proper multimedia publicity programmed is mounted to educate the consumers of all strata of society. India is still a developing country where quality and inexpensive remedy are still major issues. [ABSTRACT FROM AUTHOR]

This article will focus on the past, present and future of the generics market in Portugal, providing an overview of the main measures taken since 2000, the results achieved, as well as the new measures being prepared to increase the prescription, dispensing and utilization of generics. The generics market is consistently growing since 2000 and reached a market share of 21.4% in August 2011. The comparison of the first 8 months of 2010 and 2011 shows a total market decrease of 7.1%, a decrease of the National Health Service (NHS) expenses with medicines of 19.2%, around 200 Million€ and a generics market growth of 19.9%. The memorandum of understanding (MoU) established between the Portuguese Government and the Troika sets the goal of reducing the public health expenditure with hospital and ambulatory medicines from 1.55% of the gross domestic product (GDP) in 2010 to 1.25% of the GDP in 2012 and to 1% of the GDP in 2013. These reductions imply a decrease of 525 Million€ in 2012 (vs 2010) and around 942 Million€ in 2013 (vs 2010). In order to reach the savings with medicines established in the MoU, several measures are being taken at ambulatory level, like the 50% price reduction of the first generic in an active substance compared to the reference medicine; the removal of administrative barriers preventing the entrance of generics in the market due to intellectual propriety rights injunctions; the revision of the pharmacies remuneration scheme; the creation of guidelines for medicines’ prescription; the prescription by international nonproprietary name only and the revision of the four reference countries used for the medicines annual price revision. In conclusion, generic medicines can help Portugal overcome the crisis supporting the decrease of medicines’ public expenditure with medicines. [ABSTRACT FROM PUBLISHER]

This research examined cultural differences in the patterns of choices that reflect more social characteristics of a chooser (e.g., social status). Four studies examined the cultural difference in individuals' tendency to choose brand-name products (i.e., high-status options) over generic products (i.e., low-status options) and the underlying reasons for these differences. Compared to European Americans, Asian Americans consistently chose brand-name products. This difference was driven by Asian Americans' greater social status concerns. Self-consciousness was more strongly associated with the brand-name choices of Asian Americans (vs. European Americans), and experimentally induced social status led Asian Americans (vs. European Americans) to make more choices concordant with self-perception. These findings highlight the importance of considering external and social motivations underlying the choicemaking process. [ABSTRACT FROM AUTHOR]

This paper provides the generic pharmaceutical executive with a legal roadmap for acquiring pharmaceutical assets. It describes the three main steps to product acquisition, which are as follows: (1) negotiation and execution of a detailed letter of intent; (2) performance of buyer's due diligence; and (3) negotiation and closing of the acquisition agreement. It also explains the relationship among these three steps and why each step is important to the buyer. In discussing each step of the acquisition process, this paper identifies the key considerations and issues for the buyer to help the buyer mitigate the risks inherent in the acquisition of generic pharmaceutical assets.Journal of Generic Medicines (2008) 6, 9–14. doi:10.1057/jgm.2008.28; published online 28 October 2008 [ABSTRACT FROM AUTHOR]

This paper aims to report on the ‘Innovation through generics’ roundtable, which was convened at the European Parliament in April 2008 to discuss the role of generic medicines in stimulating innovation in the pharmaceutical sector. The roundtable identified a number of factors that hamper generic market entry in Europe and, thus, inhibit competition and innovation in the pharmaceutical sector. These factors include the decline in true innovation in the pharmaceutical sector; shortcomings in current patent and registration systems; pricing and reimbursement delays for generic medicines; greater intellectual property protection and market exclusivity for originator medicines than in the United States; price linkage between generic and originator medicines in some member states; and a lack of demand-side measures that encourage physicians, pharmacists and patients to use generic medicines. There is a need for a pan-European policy relating to patents, registration, pricing and reimbursement, prescribing and dispensing of medicines. In particular, the creation of an internal market will benefit European healthcare by helping to drive down costs. The overall goal should be to support competition and true innovation and, thus, provide sustainable healthcare for patients throughout Europe.Journal of Generic Medicines (2008) 6, 3–8. doi:10.1057/jgm.2008.30; published online 4 November 2008 [ABSTRACT FROM AUTHOR]

Biological generics are protein products comparable in quality, safety, and efficacy to the brand product and marketed after exclusivity has expired. In the US, sales of biologics are expected to exceed US60bn by 2010 while in the EU the market size for ‘biosimilars’ is estimated to be US16–20bn per year by 2010–2011. Biological drugs for which the patent period has expired or is soon to expire include insulin, human growth hormone, interferons, erythropoetin, growth factors, monoclonal antibodies, and blood factors. Not all biological products are currently candidates for various technical and scientific reasons; however, most are. The economics of biological generics will be different than chemical generics. While savings equivalent to a chemical generic may not be realised by the end user, savings in terms of absolute dollars will be substantial. In the EU, so far two ‘biosimilars’ have been approved, while in the US the FDA is reviewing and approving Follow-on Protein Products under the FD&C Act, §505(b)(2). As with chemical generics, challenges and opportunities exist. The entry of biological generics will result in rewards for all. As these products range in the complexity of their molecular structure and indications, the mantra of biologics — case-by-case drug development — will need to be followed.Journal of Generic Medicines (2007) 4, 186–199. doi:10.1057/palgrave.jgm.4950067; published online 20 February 2007 [ABSTRACT FROM AUTHOR]

The global increase in the cost of health has become an enormous issue, and one that is set to continue as a consequence of the ageing population. Pressure mounts within the big pharmaceutical companies, where there is an increasingly sharp focus on the productivity and efficiency of R&D operations. By contrast, we are seeing an almost global expansion of the generics pharmaceutical sector, a trend that is forecast to continue. Without generics, the pharmaceutical component of healthcare budgets would increase substantially, and this, in turn, would bring about further increments in the overall cost of healthcare. Whereas many people regard the generics and branded patented medicines industries as competitors, in fact they sit synergistically together. Against this background, a pharmaceutical company based in India has real potential to meet the challenge of growth and profitability on a global scale. India not only has a long and successful history in generics but also possesses many inherent competitive advantages, a key one being the low cost of innovation, for succeeding in the area of drug discovery. If the current productivity seen in India can continue with a conscience, and be expanded through optimal and cohesive communication with key customers in the Western world, this will lead to significant shareholder wealth and benefit to patients. [ABSTRACT FROM AUTHOR]

As generics markets are becoming more mature, size is playing an increasingly important role. Larger companies and niche players may be able to sustain their profitability by making adjustments to their operations, but mid-sized competitors see their existence as being threatened. Owners and managers at these firms are discussing a wide range of options. Viable options for mid-sized generics businesses follow a limited number of strategies. Waiting for better times is not on that list. [ABSTRACT FROM AUTHOR]

This article presents several legal and regulatory updates related to generic drugs in European Union (EU). If a trademark owner has not agreed to the importation of its products into the European Economic Area (EEA), the importation of its products is deemed illegal and the importer can be fined and jailed for a period of six months to two years. These penalties apply even in the event that the products in question have been bought legally in non-EEA countries. The differences between registrations for medicinal products in the various states force many foreign citizens to give up, in their host country, the medicines they normally use for their treatment. The Commission states that citizens of the EU living in a member state other than their country of origin, can obtain their usual medicines in their new host country, in so far as these medicines are authorized in that member state or that a marketing authorization has been obtained from the Community.

With many first-generation biologics losing patent protection within the next couple of years, there is an ever-increasing need to develop biogenerics. Biogenerics face a steep road to US Food and Drug Administration (FDA) approval for a variety of reasons. This paper focuses on the two major issues currently facing the biogenerics industry: scientific issues (including characterisation of the biological product, demonstration of bioequivalence and manufacturing issues); and regulatory issues (including an approval process for the biogenerics). [ABSTRACT FROM AUTHOR]

In this paper we address questions of 'shopping as practised' and its relation to shopping space. We argue that modes of shopping, which comprise distinctive sets of shopping practices involving relations to goods (purchases), relations of looking (and seeing), the place of shopping in the rhythms of everyday life, and the socialities of shopping, are used to invest meaning in particular types of shopping space and to produce individual, accumulated, personalised shopping geographies that weave together particular locations and generic spaces. Furthermore, modes of shopping are shown to require specific sets of knowledge to practise and to relate to specific subject positions, namely necessity and choice. These arguments are developed in relation to charity shops and charity shopping. However, they are shown to have broader implications: specifically they show the relationality of modes of shopping and shopping spaces, and the distinctions between shopping geographies and retail geographies. Theoretically, they suggest that accounts of shopping need to locate meaning in practice; that the meanings of shopping (and the meanings invested in particular shopping spaces) are therefore potentially unstable; and that accounts of the constituting subjects of shopping need to take seriously the spatialities of subjectivities. [ABSTRACT FROM AUTHOR]

The worldwide generic market should keep on growing at the expense of brand-name companies and reach sales of US$97bn, in 2010. To resist this increasing competitive pressure and to maintain a slice of the market, brand-name companies may negotiate with generic companies to postpone the launch of their competitive products or they may license their own generic products to competitor generic companies. In the USA, these so-called ‘authorised generics’ have generated substantial profits for brand-name companies and to their generic partners, provided however that they are launched before patent expiry during an exclusivity period. In Europe, there are no legal exclusivity periods granted to generic companies that can challenge original brands, and the strategic and financial values relative to this strategy are not well established. This paper proposes a specific approach to assess the benefits of authorised generic deals for both the brand-name companies and their generic partners. The application of this approach on several authorised generic deals carried out in France shows that the duration of the exclusivity period, the number of generic partners involved, and their relative competitive position are the most important success factors. In addition, it appears that brand-name companies could have a financial interest to propose, for their ‘easy-to-substitute’ original brands, authorised generic licenses to all generic companies. In such a situation, generic partners will benefit from a guaranteed market access and a product identical to the original brand while avoiding risks of patent infringement.Journal of Generic Medicines (2007) 4, 106–116. doi:10.1057/palgrave.jgm.4950061; published online 19 December 2006 [ABSTRACT FROM AUTHOR]

Medical policy analysts and oncologists have cautioned against the high price of anticancer drugs. They argue that the current drug development model that relies on patents and short-term shareholder value is proving unsustainable, since the cost of the new generation of drugs puts many of them out of reach for the average consumer. The high price of cancer drugs is especially troubling in the context of middle- and low-income countries, where the burden of cancer carries disproportionate impact. To analyse the pricing of anticancer drugs, we examined legal controversies, regulatory treaties and documents, as well as the history of pricing data in India. We also conducted interviews with policy consultants and surveyed financial data filings of major global and Indian pharmaceutical corporations. Our research revealed that global trade agreements have become key barriers to lowering anticancer drug prices. This article argues that in the shadow of the World Trade Organization (WTO) and with Trans-Pacific Partnership (TPP) imminent, serious policy changes are necessary to ensure the survival of generic production in the market for anticancer drugs. [ABSTRACT FROM AUTHOR]

Focuses on the anticompetitive nature of brand-name manufacturers' introduction of generics before patent expiration. Theory of predatory pricing; Illustrative cases; First-mover advantages; Entry lags; Raising rivals' costs.

This paper discusses the nature of generic biopharmaceutical products and the barriers to their entry into the market. It reaches the conclusion that there are substantial rewards to be had for the first company to be successful, but that market entry may take longer than many observers think. To be successful, a company must be able to make the product to the required quality standards, to navigate the emerging regulatory pathways successfully and to market the product effectively. In each case the challenge is different, and more complex, than that facing synthetic generic products. [ABSTRACT FROM AUTHOR]

This paper provides an overview of key regulatory and technical issues related to the approval of biotechnology products in the USA by an abbreviated pathway. Technological advances now permit accurate analytical comparisons of innovative and generic biotechnology products. These sophisticated analytical techniques, along with pharmacodynamic, pharmacokinetic and limited clinical testing, provide an array of comparative tools to demonstrate the equivalence of innovative and generic products. Using a case by case evaluation, there are currently biotechnology products that could be approved based on abbreviated data packages. [ABSTRACT FROM AUTHOR]

The article comments on the legislation that will allow generic biotechnology to compete with the biotechnology industry in the U.S. According to the author, the fight for competition in the pharmaceutical industry was concluded when the Drug Price Competition and Patent Restoration Act was legislated. Biotechnology were not yet included in the legislation. The Food and Drug Administration likes Congress to decide on the issue. The Congress has decided to take on the challenge.

This article presents an overview of the implementation of key elements (Target Product Profile, Critical Quality Attributes, design space and control strategy) of Quality by Design (QbD) – a systemic approach in the case of generic drugs. The basis for this concept is that advanced understanding of variables affecting generic drug (product) quality, either obtained through historical operation or demonstrated through process modelling, justifies the replacement of the traditional process targets with acceptable operational ranges. This article also describes the steps involved in the development of generic drugs, steps through which the QbD concept can be applied, and the opportunities for and challenges to implementing QbD in generic drug development. [ABSTRACT FROM AUTHOR]

The generic pharmaceutical sector has witnessed an unprecedented level of mergers & acquisitions (M&A) activity in recent years. Companies are engaging in merger activity to strengthen their strategic positioning in response to the changing competitive landscape in the industry. In a growing global generic market, having adequate scale and financial strength will be key attributes to manage pressure on pricing and margins, capture growth opportunities globally, establish a competitive cost base, and be able to pursue high value but high investment opportunities in niche generics and biologics. The emergence of a tier of large leading generic companies as well as the renewed interest by big pharma in the generic market are forcing industry participants to determine their strategy and role towards the consolidation trend. In an industry that remains highly fragmented, the changing market environment is expected to lead to continued M&A activity which will change the shape of the industry in the future. [ABSTRACT FROM AUTHOR]

Over the past several years, there has been a perception in the generic industry that brand companies have been using the Citizen Petition process with the US Food and Drug Administration in order to extend the lifecycles of their brand products and prevent or delay approvals of generic applications. While these filings lend credence to this perception, it nonetheless leaves open questions regarding purpose and effect. This paper examines Petition filings since 2004 and explores their purported purpose, their likely purpose, and impact on generic market dynamics.Journal of Generic Medicines (2007) 4, 87–97. doi:10.1057/palgrave.jgm.4950060; published online 19 December 2006 [ABSTRACT FROM AUTHOR]

The author discusses the future of generic gadolinium-based contrast agents. The author mentions the trends and changes in the use of contrast agents and the cost effectiveness of introducing generic agents. The author also cites how generic gadolinium-based contrast agents differ from other drugs in terms of research, publication of results, package-insert, and summary of product characteristics.

The article presents a study that evaluates the knowledge and perceptions of physicians from private medical centres towards generic medicines. The study included 172 physicians in 16 private medical centres in Perak, Malaysia. It suggests that physicians in private sector still have some concerns and misconceptions about generic medicines.

Pharmaceutical companies have traditionally relied on product-specific in-person calls to physicians (detailing) to market their drugs. However, US pharmaceutical sales representative access to physicians is decreasing, resulting in important changes in marketing strategy, sales force optimization and operations, and other processes. Despite these changes, no studies have examined the determinants of pharmaceutical sales representative access limits to physicians. We analyzed effects from prescription volume, managed care control, group practice size, urban location, and physician-level attributes for three product cases involving type 2 diabetes and dyslipidemia covering 58,647 to 72,114 US physicians using an ordered multinomial logistic regression model. A database available to and used by US pharmaceutical companies was utilized that measures sales representative physician-level access limits. Results revealed physicians with moderate managed care control had greater access limits than physicians with high or low managed care control, as did physicians with higher prescription volume, in smaller practices, and fewer years since graduation. Access limits also significantly varied by specific urban location. The results fit a time allocation model explaining how physicians and sales representatives allocate their time, and suggest effects from physician adoption of newer digital channels for medical information and changing norms at medical schools toward industry representatives. Commercial implications of restrictive access limits for companies are discussed as well as future extensions of this research. [ABSTRACT FROM AUTHOR]

The worldwide generic market doubled, in volume, over the past 10 years. It appears, at first sight, very attractive. However, generic companies’ profitability is on average lower than that of R&D-based companies and their future risk of deterioration higher due to stronger commoditisation. The attractiveness of generic markets being significantly different from one country to the other, thus, the author proposes an approach, that he has applied to the French market, to assess country-specific business opportunities and threats. The analysis of different stakeholders shows that the French generic market development has been driven by a series of governmental measures to encourage physicians to prescribe, pharmacists to substitute and deliver, and patients to accept generic products. Physicians, who did not play a major role so far, could be asked to prescribe significantly more generic products, or at least more genericized brands, so that pharmacists can substitute them. Retail pharmacists, who substitute more than 70% of genericized brands, have been instrumental in the development of generic products and will be asked to further increase their substitution rate. Patients, of whom almost two-third accepts generic products, are not expected to change their attitude over the short term. Generic companies, operating in France are in danger due to anticipated price cuts of the government in one hand, and the refusal of retail pharmacists to accept any decrease of their discounts, in the other hand. In such an increasingly unattractive environment, survivors will be the biggest generic companies which will manage to secure the lowest production costs and the highest Generic Preference Mix index. [ABSTRACT FROM AUTHOR]

The study aims to translate and validate the generic medicine scale (GMS) among the Malaysian population. A standard “forward–backward” procedure of translation was used and the translated version was then validated on a convenience sample of 202 patients. Face validity of translated GMS was confirmed with pilot testing. Content validity of the translated GMS was evaluated by eight postgraduate students who are experts in the field. For reliability, the instrument demonstrated good internal consistency (Cronbach’s α = 0.734) with correlation coefficient ranging from 0.198 to 0.500. Alpha value for efficacy dimension of the scale was 0.623 and for similarity dimension was 0.716. The test–retest reliability of the GMS indicates good reliability and stability of the instrument with Spearman’s rank correlation coefficient of 0.532 (rs = 0.532, n = 202, p = 0.005). In conclusion, the Malaysian version of the GMS is a reliable and valid measure of patients’ belief about generic medicines. [ABSTRACT FROM PUBLISHER]

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called ‘biosimilar’ products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.Journal of Generic Medicines (2009) 6, 237–245. doi:10.1057/jgm.2009.8 [ABSTRACT FROM AUTHOR]

This paper originates from a ‘Generics Industry Forum’ that debated the development of the Japanese generic medicines retail market. Based on these discussions, the paper conducts a descriptive analysis of Japanese generic medicines policy and proposes recommendations for further developing the market by learning lessons from the European experience. The Japanese generic medicines market has benefited from measures that assure supply and quality of generic medicines, provide information about generic medicines, speed up registration of generic medicines on the reimbursement list, allow and reward generic substitution by pharmacists, increase patient co-payment, and reward physicians who adopt generic prescribing and/or who allow generic substitution. However, several factors hamper the development of this market, including extensions to the data exclusivity period and patent term of originator medicines, the requirement to launch the same generic medicine strengths as the originator medicine, mandatory reductions of reimbursement tariffs and weak incentives for physicians, pharmacists and patients to demand generic medicines. In order to sustain the development of the Japanese generic medicines market, a number of avenues were proposed that focused on speeding up market access of generic medicines, implementing a reference-pricing system and strengthening incentives for physicians, pharmacists and patients to demand generic medicines.Journal of Generic Medicines (2009) 6, 129–135. doi:10.1057/jgm.2009.4 [ABSTRACT FROM AUTHOR]

This paper is about the key points of debate in generic licensing agreements, considering the objectives of the licensor and licensee. It offers compromise solutions that should help business development professionals in the generic industry in the portion of their job requiring negotiations as licensor and licensee, with the common objective to bring affordable medicines to those who need them, while increasing profits.Journal of Generic Medicines (2007) 4, 180–185. doi:10.1057/palgrave.jgm.4950069 [ABSTRACT FROM AUTHOR]

Recent changes in perspective at the US Food and Drug Administration and in the EU have clearly indicated a commitment to an abbreviated development and regulatory pathway for follow-on biological drugs (or biogenerics). This process has been discussed only in fairly abstract terms, however, and definitions and concrete requirements that could guide manufacturers of these products with regard to data requirements for an abbreviated submission are still needed. The aim of this paper is to summarise some of the critical scientific issues that will have an impact on the development of programmes for biogenerics. This paper discusses in some detail the likely necessity for developers of biogenerics to chemically and structurally characterise both their own follow-on product as well as the innovator's product in order to demonstrate a sufficient level of biosimilarity. Issues related to the characterisation of a biogeneric's biological activity are discussed, as are issues related to toxicity risks. It is the authors' belief that the term'biosimilar', as opposed to the high level of required structural identity between a generic chemical drug and its innovative product, best describes the nature of follow on biologics that would qualify for expedited development. Interpreting the clinical importance of demonstrated dissimilarities between innovator and biosimilar products is likely to be the greatest challenge for manufacturers of biogenerics, with requirements for human clinical testing being decided by regulatory agencies on a case by case basis. [ABSTRACT FROM AUTHOR]

Times are changing in biotechnology. With the expiration of patent protection for some of the most profitable biologics in the next few years, a new, fast-growing field has started to emerge: 'biogenerics'. Known as 'similar biological medicinal products' or 'biosimilars' in Europe, these products are about to enter the now-enlarged Community market. A number of uncertainties and challenges still lie ahead, though. To regulate biosimilars means dealing with complex molecules, which are tricky to characterise and highly sensitive to manufacturing changes, to which a 'classical' generics approach is not directly applicable. Specific legislation needs to be put in place. While hearings regarding the need for special regulation on 'biogenerics' are now being held in the USA, European regulatory authorities have taken the lead by establishing a tailor-made legal framework for biosimilars with the publication of the so-called 'Annex I', in 2003. Further developments are expected with the revision of the EU pharmaceutical legislation (the Pharma Review), which was adopted by European institutions in 2004. The purpose of this article is to provide an overview of this framework, the main consequences of the Pharma Review and a discussion on key points to be considered when entering this emerging market. [ABSTRACT FROM AUTHOR]

It is in doubt about whether response of government hospitals to prescription cost savings can be evaluated through hospital formularies. The objective was to determine a measure reflecting such response and methods to increase it. An observation on products in a government hospital formulary included their numbers; prices; classes; category, essential medicine (EM) or non-EM; EM sub-lists, List A (basic) to List E; type, generic or brand; and hospital availability, single or dual. The numbers and prices of products were associated with the topics observed. A dominant character of EMs was to increase the numbers, but that of generics was to decrease the prices of products. Single availability expanded the prices of generic and brand products but dual availability narrowed them. For generic products, the numbers decreased but the prices increased from basic to upper EM sub-lists. A hospital formulary could reflect trend of prescription and cost, therefore it is clear that response to prescription cost savings could be determined through it. Proportion of products that are both EM and generic has been considered as measures indicating such response. Including more EMs and generics and delisting unnecessary brands in the basic EM sub-list and major classes could enhance the response. [ABSTRACT FROM AUTHOR]

Objective: To assess the magnitude of generic-generic and brand-generic medication switching and its impact on patients' understanding and the potential risk of medication errors. Methods: The study composed of 2 parts. The first part is a retrospective study to measure the frequency of medications switching in King Faisal Specialist Hospital and Research Centre (KFSH&RC), from 1st of January 2015 to the 31st of December, 2020. Brand medications that were switched to generic medications, generic medications that were switched to brand medications and generic medications that were switched to other generic medications were included. Medications that were switched before or after the study period were excluded. The primary outcomes are the total percentage of switching from brand to generic of all medications in KFSH&RC drug formulary, frequency of generic-generic medications switching and percentage of switching back from generic to brand medications. The second part is a cross sectional survey-based study to assess patients' understanding of their medications and the potential for medication errors by assessing their ability to identify the discrepancies and duplications utilizing a validated questionnaire. Results: Over 5 years, the number of generic medications increased from 553 (35.5%) to 640 (41.1%) out of the 1554 formulary items. Percentage of switching from brand to generic over that 5-year period was 15.9%. Percentage of switching back from generic to brand was 12.8%. Total number of generic medications that had been switched to other generic medications was 256 (16.5%). Out of the 218 patients who had been switched from generic to generic medication, only 43 patients (19.7%) knew the indication for the generic medication they were taking. One hundred forty-six patients (67%) knew the indication of generic medications exclusively by their physical "trademark" characteristics, with 11.5% unrecognized duplication. Conclusion: There is a clear tendency to switch brand medications to generics and to switch between generics. We found the percentage of subsequent switching back to branded products is alarming. Frequent switching between medications negatively impacted patient comprehension and resulted in medication duplication. There is a crucial need for appropriate medication counseling and medication use ecosystem redesign. [ABSTRACT FROM AUTHOR]

To meet the challenge of ensuring quality medicines to the American public and proactively prevent drug shortage situations, the Center for Drug Evaluation and Research has formed its newest super-office, the Office of Pharmaceutical Quality. This office integrates review of drug applications with the evaluation of manufacturing facilities for a more informed quality assessment. It also promotes a lifecycle approach to quality that integrates functional areas, data, and processes and provides a drug product knowledge base. This article describes the roles and responsibilities of Office of Pharmaceutical Quality during the quality assessment and lifecycle management of generic drug products. [ABSTRACT FROM AUTHOR]

In her speech launching DG Competition's preliminary report on the pharmaceutical sector inquiry on 28 November 2008, Commissioner Neelie Kroes clearly identified the Report's unspoken conclusion ‘competition in this industry does not work as well as it should’. Among others, the Report rightly identifies delays to generic entry as an important failure of the competitive process in the pharmaceutical sector. The result is that national health-care systems (and patients) pay unnecessarily high prices for pharmaceuticals and, ultimately, that patients are unable to obtain the medicines they need. The behaviour of originator companies is correctly stated to be a significant factor in delays to the entry of generic medicines. As set out in the Report, originator companies have a ‘tool box’ of strategies that they deploy to frustrate the entry of generic medicines. In the opinion of the European Generic Medicines Association (EGA), a number of strategies is the most significant in creating hurdles to generic competition. In highlighting these strategies, the Report confirms the experiences of generic companies operating in Europe. The EGA's members regularly encounter use of each of these strategies when seeking to launch new generic products in EU markets, and will frequently encounter the use of multiple strategies by an originator company in relation to a single medicine and across a range of Member States.Journal of Generic Medicines (2009) 6, 188–192. doi:10.1057/jgm.2009.9 [ABSTRACT FROM AUTHOR]

The International Society of Oncology Pharmacy Practitioners organized a workshop to create learning opportunities on biosimilars in pharmacy practice on 10 October 2019. The topics that were covered included (i) the development and testing of biosimilars, (ii) the challenges of bringing biosimilars to market, and (iii) real-world data on patient safety and perceptions during biosimilar implementation. The development of biosimilars can take up to eight years and the extensiveness of the process depends on several factors, such as the complexity of the production process and regulatory requirements. Compared to generic products of small-molecule drugs, there is a higher barrier to market entry for biosimilars, explaining the small number of biosimilars in the market. Appraisal of biosimilars for inclusion in hospital formularies is also different from the review process of originator biologics, where the former is usually institution-led and has fewer restrictions on use. When several biosimilar products are available, factors that should be considered besides cost are licensed indications, supply chain confidence, clinical data, and product attributes. Real-world data have shown that biosimilars are well-tolerated and have safety data that are comparable to that of the originator product. Oncology pharmacists from the United Kingdom, Kenya, and Canada also presented their respective experiences with biosimilar use. Different countries at varying stages of biosimilar implementation faced distinct challenges. Nevertheless, resources to assist biosimilar implementation can potentially be shared between different regions. International Society of Oncology Pharmacy Practitioners is well-positioned to foster professional cooperation at an international level to drive biosimilar implementation. [ABSTRACT FROM AUTHOR]

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed. [ABSTRACT FROM AUTHOR]

Background: Suboptimal knowledge and attitude of healthcare professionals about generics reduce utilization of these drugs. The objective of this study was to assess the knowledge gap, attitude and practice among pharmacy professionals toward generic medicine in Addis Ababa, Ethiopia. Method: The study was conducted in Addis Ababa from 10 April to10 July 2018 among 424 pharmacy professionals. Self-administered questionnaire was used to collect the data. Data were analyzed by using statistical package for social sciences version 24 and multi-variable binary logistic regression was used to identify predictors of the dependent variables. Result: Majority (77.1%) of the participants claimed that they have had knowledge on the concept of generic medicine. Knowledge was significantly associated with participants' educational qualification and work experience. More than half (55%) of them have an attitude that brand medicines are of higher quality compared to generics and 37.6% of them believe generic medicines are less effective than brand medicines. About 80% of the participants claimed that locally manufactured generics are cheaper than imported generics. Affordability to the customer, cost effectiveness of generic medicine and consumer preference/demand were the commonest reasons to dispense generic medicines. Conclusion: Though vast majority of the study participants have had knowledge on the concept of generic medicine, their attitude and practice seem suboptimal that will influence utilization of generic products. [ABSTRACT FROM AUTHOR]