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The treatment of moderate-to-severe plaque psoriasis has seen significant improvements in recent years with the advent of biologic drugs. The aim of this study was to assess the cost-effectiveness of anti-IL17 drugs and other biologic therapies used to treat moderate-to-severe plaque psoriasis in France and Germany over a one-year time horizon. We developed a cost per responder model for biologic drugs used in psoriasis treatment. The model included anti-IL17s (brodalumab, secukinumab, ixekizumab and bimekizumab), anti-TNFs (adalimumab, etanercept, certolizumab and infliximab), an anti-IL12/23 (ustekinumab), and anti-IL23s (risankizumab, guselkumab and tildrakizumab). Efficacy estimates were collected through a systematic literature review of network meta-analyses on long-term Psoriasis Area and Severity Index (PASI) measures. Dose recommendations and country-specific prices were used to calculate drug costs. Biosimilar drug prices were used when available as a substitute for the originator drugs. After one year, brodalumab had the lowest cost per PASI100-responder in both France (€20,220) and Germany (€26,807) across all available biologic treatments. Among the anti-IL17s, brodalumab had a 23% lower cost per PASI100-responder vs. the nearest comparator in France (bimekizumab, €26,369), and 30% lower vs. nearest comparator in Germany (ixekizumab, €38,027). Brodalumab also had the lowest cost per PASI75- and PASI90-responder among the anti-IL17s in both France and Germany after one year. Adalimumab had the lowest cost per PASI100-responder among the anti-TNFs in both France (€23,418) and Germany (€38,264). Among the anti-IL-23s, risankizumab had the lowest cost per PASI100-responder in both France (€20,969) and Germany (€26,994). Driven by its lower costs and high response rates, brodalumab was the most cost-effective treatment option for moderate-to-severe plaque psoriasis over a one-year time-horizon within the anti-IL17 class and when compared to all other biologics in France and Germany. [ABSTRACT FROM AUTHOR]

TNF-alpha inhibitors have revolutionized the therapeutic care in chronic inflammatory diseases. Several biosimilar products were commercialized at their patent expiry, substantially decreasing the cost of treatment. This longitudinal descriptive study aimed at assessing infliximab, etanercept and adalimumab biosimilar penetration rates using data of the French National Health Data System. A total of 207,118 new or prevalent users from the date of first biosimilar commercialization in France (respectively January 2015, May 2016 and October 2018) were included in the study and followed until September 30, 2021. Biosimilars represented respectively 78%, 46% and 53% of the overall initiations, and 94%, 66% and 60% last year's initiations. A total of 46%, 19% and 17% of originator product prevalent users switched for a biosimilar during the follow-up. Biosimilar penetration rate was much higher for infliximab than for its counterparts, due to its hospital delivery modality. Biosimilar initiation and originator-to-biosimilar switch tended to be observed more in rheumatology than in the other specialties. Biosimilar use was mostly consistent across patient socio-demographic characteristics. Biosimilar initiation rate increased rapidly from their market arrival and originator-to-biosimilar switch rate remained moderate, highlighting the need and usefulness of political action and biosimilar use tracking. [ABSTRACT FROM AUTHOR]

Objectives: To assess the economic impact of introducing biosimilar pegfilgrastim compared to the current standard granulocyte colony-stimulating factor (G-CSF) practice in France. Methods: A budget impact model was developed to investigate the impact of introducing pegfilgrastim biosimilar over 5 years. The model analysed drug acquisition costs, ambulatory costs, as well as costs associated with poor outcomes, and compared the current standard practice of long-acting and short-acting G-CSF to a revised practice including pegfilgrastim biosimilar in addition to standard practice treatments. The cost of switching to pegfilgrastim biosimilar, within a pharmacy setting, was analysed within the model using data from a survey of French pharmacists. Results: The budget impact model calculated a cost saving of €51,007,531 over 5 years switching from the current standard practice to pegfilgrastim biosimilar. A sensitivity analysis accounting for variation in pegfilgrastim biosimilar uptake of 1) 15% in year 1 and 1% in years 2–5 and 2) 15% in years 1–5, estimated savings ranging between €29,377,784 and €79,847,194, respectively. A further analysis predicted cost savings of €287,344,835 over 5 years with the extension of pegfilgrastim biosimilar, at an uptake of 15% in year 1 and 7% in years 2–4, to both long-acting and short-acting G-CSF groups compared to unchanged current practice. Conclusions: The introduction of pegfilgrastim biosimilar will help to reduce cost and alleviate some of the financial pressure on the French healthcare system. [ABSTRACT FROM AUTHOR]

France has a single-payer health insurance system that has the authority to impose pharmaceutical price reductions but relies on decentralized market negotiations between hospitals and manufacturers to establish prices for injected and infused biologies. Hospitals rely on biosimilars--less expensive but therapeutically equivalent variants of biologic medications--to stimulate competition. Price reductions negotiated by hospitals subsequently are adopted by the health insurance system, driving hospitals to negotiate a new round of discounts. This article measures 2004-20 trends in prices, price reductions, utilization, and market shares for three prominent biologies--Remicade, Enbrel, and Humira--and their eleven competing biosimilars. Biosimilar launches are associated with a sequence of price reductions for the reference biologic, for other biologies that treat similar conditions, and for all related biosimilars. The French experience provides lessons for the US in its efforts to use competition from biosimilars to drive price reductions and savings from biologies. [ABSTRACT FROM AUTHOR]

To identify pharmaceutical spending-control options for the United States, we analyzed the policies of the United Kingdom, France, and Germany, which encourage drugmakers to undertake innovations that improve health while controlling spending. Their main strategies today include: using legislation to set default rules that increase the insurer's bargaining position, employing health technology assessment that measures cost-effectiveness or comparative effectiveness and caps the purchase or reimbursement price, setting a single maximum price for similar drugs (reference group pricing), capping prices near prices in other European countries (external reference pricing), prohibiting price increases, contracting to obtain discounts as sales volume rises, procuring drugs through competitive bids, and requiring manufacturers to pay rebates when spending exceeds a global budget. Each strategy addresses a distinct cause of high spending and supports overall goals. Most recent US reform proposals recommend incremental changes that would not address the major sources of high and increasing pharmaceutical prices. However, some US reform proposals resemble certain European strategies and could bring more significant change. US policymakers should consider adopting each of the strategies employed in these countries. [ABSTRACT FROM AUTHOR]

Objectives: To describe the switch to biosimilar etanercept (bETN), evaluate factors associated with this switch, and evaluate the efficacy of this switch in a real-life setting Methods: We included patients, from October 2016 to April 2017, with rheumatoid arthritis (RA) and spondyloarthritis (SpA) who received innovator ETN (iETN) for at least 6 months. After receiving information on biosimilars, all physicians were invited to propose a switch from iETN to bETN. Factors associated with bETN discontinuation were explored by univariate and multivariate analyses. We estimated the proportion of patients still on bETN over time by Kaplan-Meier survival analysis. We assessed serum trough concentrations of iETN and bETN and anti-drug antibodies to ETN. Results: Overall, 183 outpatients were eligible for a potential switch; 94 (51.6%) switched from iETN to bETN. The probability of a switch was greater with an older than younger aged physician (mean [SD] age 50.4 [14.3] with a switch vs 44.8 [11.3] with no switch, p = 0.005) and the physician having a full-time academic position than other position (56.4% with a switch vs 13.5% with no switch, p < 0.001). After a 6-month follow-up, bETN retention rate was 83% (95% CI: 0.76–0.92). The first cause of bETN discontinuation was inefficacy (50%). On multivariate analysis, no factor was independently associated with a bETN switch or discontinuation. Drug trough levels did not significantly differ by discontinuation or continuation of bETN. No patient showed anti-drug antibodies. Conclusion: The probability of switching from iETN to bETN was likely related to physician characteristics. [ABSTRACT FROM AUTHOR]

Objective: To compare the market dynamics of biosimilar infliximab among four Organization for Economic Cooperation and Development (OECD) countries (UK, France, Japan, and Korea) where supply-side and demand-side policies varied greatly, given high and growing expenditure on biological medicines to treat immunological diseases across countries. Methods: A quarterly dataset covering October 2012 to March 2018 was constructed from the MIDAS-IQVIA International database. The sales value (in USD) and volume (in standard units) of originator infliximab and biosimilar products and their relative price in each country were compared. Results: With the introduction of biosimilars, the sales value of infliximab increased approximately 2.5 times in Korea, whereas it only slightly increased (1.2 times for France and the UK) or decreased (0.9 for Japan) in other countries. While stable market size dynamics were observed in the other countries, an escalating market size, attributable to the increase in originator infliximab, was observed in Korea. In the UK and France, which have implemented demand-side policies, the sales volume of originator infliximab appreciably decreased after the entry of biosimilar infliximab while that of biosimilars increased; however, in Korea, which has supply-side policies based on price-linking with few demand-side policies, the volume of originator infliximab actually increased by 70% alongside a very limited increase in biosimilar infliximab. The lowest price ratio between biosimilar and originator infliximab was found in Japan, at 68%. In France and Korea, the ex-factory prices of biosimilar infliximab were 99 and 95%, respectively, of the originator infliximab price. In the UK, the ex-factory price of biosimilar infliximab started at 87% of that of originator infliximab and then decreased to 80% as the market matured. However, actual price differences might differ. Conclusion: The uptake of biosimilar infliximab varied greatly, and in contrast to the UK, France, and Japan, the introduction of biosimilar infliximab resulted in market expansion in Korea, which might be explained by a lack of demand-side policies in Korea. Both supply- and demand-side measures are necessary for health authorities to achieve desired savings from the availability of biosimilars. [ABSTRACT FROM AUTHOR]

Objectives: Biologic disease-modifying antirheumatic drugs (bDMARDs) are prescribed sequentially in the treatment of rheumatoid arthritis (RA). Healthcare decision makers continue to debate their use, mainly because of their high costs. Our aim was to perform an economic evaluation for France of bDMARD sequences for treatment of moderate-to-severe RA after inadequate response or intolerance to conventional DMARDs (eg, methotrexate).Methods: A discretely integrated condition event simulation was developed to track the course of patients from first bDMARD through switches to further lines in a sequence. The model included 11 events, 91 conditions, and 21 controlling equations. Inputs were obtained from a meta-analysis of clinical trials, a French registry, national drug lists, and databases. Survival, time with minimal activity, quality-adjusted life-years (QALYs), and total costs were output. Structural and probabilistic sensitivity analyses were conducted.Results: Sequences starting with etanercept biosimilars (ETB) cost less, with ETB-abatacept-infliximab the least expensive: the mean lifetime discounted total cost was €116 912 per patient, with a mean of 11.166 QALYs. Most other strategies were dominated or led to small QALY gains (0.0008-0.0329). Only ETB-tocilizumab-abatacept made it onto the efficiency frontier, but at €955 778 per QALY gained. These results were confirmed in several scenarios and uncertainty analyses.Conclusion: Given minor differences in QALYs gained between bDMARD sequences with large cost differences, starting with biosimilars was more efficient than starting with branded products. Our model and findings should provide French and other decision makers with useful tools to address the challenges of comparing sequences of treatments for RA. [ABSTRACT FROM AUTHOR]

Background: The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropenia-inducing chemotherapy (CT).Methods: Patients ≥ 18 years undergoing CT for a malignant disease and with a first prescription for Zarzio® were enrolled in two cohorts according to tumour type: solid tumour or haematological malignancy; results from the solid tumour cohort are reported here. Analyses primarily described the prescription and use of Zarzio® in current practice, and also included identification of factors linked to prescription for primary prophylaxis and comparison of Zarzio® use in relation to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.Results: Responses were obtained from 125 physicians and 1179 patients with solid tumours, allowing robust statistical analysis of the data. Use of Zarzio® in clinical practice was relatively standardised and followed label indication. The patient profile was in line with EORTC guidelines for granulocyte colony-stimulating factor (G-CSF) febrile neutropenia (FN) prophylaxis, and the majority of patients had ≥ 1 EORTC factor(s) for increased risk of febrile neutropenia. Some patients (10.8%) received Zarzio® despite receiving CT regimens categorised in guidelines as low (< 10%) FN risk ('over prophylaxis'). Nearly half of patients' CT regimens did not have a recommended FN risk category. Zarzio® was commonly initiated as primary prophylaxis; initiation in Cycle ≥ 2 of the current line of CT was associated more with a history of neutropenia. The safety profile of Zarzio® was confirmed.Conclusions: Use of Zarzio® in routine clinical practice is generally in line with EORTC guidelines for prophylaxis of CT-induced neutropenia. Patient-related risk factors appear to be a stronger driver of clinicians' decision to initiate Zarzio® than CT risk category for FN. The intrinsic risk of FN associated with a specific CT protocol is often miscategorised by physicians. In contrast to earlier reports of underuse of G-CSF prophylaxis, over prophylaxis is observed in a small subgroup of patients with FN risk of < 10%. [ABSTRACT FROM AUTHOR]

The future of the pharmaceutical industry lies with biotechnology. Biological drugs are complicated, expensive products used to treat complex conditions but their contributions to public health are important. A number of biopharmaceuticals on the market have seen their patent protection expired which led to the development of biosimilars. Biosimilars are embedded in the field of biotechnology and their use in therapeutics raise some questions with respect to their safety because of complex production methodologies. This paper summarizes the French law regarding the safety and the development of such drugs. [ABSTRACT FROM AUTHOR]

The rationality of the interchangeability of biosimilars is based on broad scientific evidence and numerous clinical experiences in real life which show no sign of reduced efficacy or different tolerance compared to the original molecule. The substitution of biosimilars (pharmaceutical act) remains widely contested in many countries, notably in France. However, it would make it possible to make very significant savings in a context of major acceleration in health spending. This reluctance is unfounded in light of the quality of biosimilars authorized in Europe and their rigorous evaluation. It is therefore essential to improve the information of health professionals and patients on these biosimilars., (Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Biosimilar drugs are biologic drugs clinically similar to the reference products. They correspond to a generic approach applied to biologic agents. Biosimilars are aimed to provide cheaper drugs by enhancing the concurrency. The approval of biosimilars is abbreviated when compared to that of the reference biologics but includes clinical trials (distinguishing them from the generics). Current available biosimilars in oncology are filgrastim and epoietin alpha. In the next future, will be launched rituximab and trastuzumab. In France, the development of biosimilars is faced with many hurdles that necessitates a better information of physicians and a greater price discount in the out-patient setting. More globally, harmonisation of recommendations particularly concerning extrapolation of indications and nomenclature are needed for a better acceptance., (Copyright © 2016 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

The annual "LabEx MAbImprove industrial workshops" are primarily intended to provide scientists involved in therapeutic antibodies, a comprehensive view about topics of interest for the pharmaceutical industry. They are organized by the "LabEx MAbImprove industrial committee", for this first edition especially in partnership with ARITT, the regional agency for innovation and technology transfer which operates in the French Région Centre, the 1st French region for pharmaceutical production. The 2013 edition, held May 28 at the Vinci Center of Tours, was dedicated to antibody biosimilars. Depending on opinions, the impending expiry of antibody patents and the imminent marketing approval of competitors to blockbusters can be perceived as good or bad things. Fears or opportunities? Risks for patients? Breath of fresh air for the health systems? Opportunity for re-industrializing France? In this context, it is necessary for people to form a fair and informed opinion on the current landscape of antibody biosimilars. In particular, this is especially important for scientists from the academic world, from the industry or from the regulation agencies, for pharmacists, for pharmacovigilance specialists, for health authorities, and staff from health insurance and decision makers. The first session was devoted to market and regulatory issues, and included both an overview of the evolution of the patent landscape and a description of biosimilars regulation in the European Union (EU). This session was closed by a talk on manufacturing processes for biosimilars. In the next session, quality control attributes of biosimilars were discussed and compared with the consistent quality of biotechnology products to raise the question: "How close is close enough?" In vitro assays for evaluating the Fc function of therapeutic antibodies were also discussed. The third session focused on development of biosimilars and primarily on the stepwise process for introducing an antibody biosimilar on the EU market, and included a presentation of the ongoing clinical evaluation of an infliximab biosimilar. The session concluded with a rich debate on the indication extrapolation of a biosimilar compared to the originator. The last session was dedicated to societal issues and focused on two aspects: (1) the need of biosimilars for EU health economy; and (2) last but not least, the ethical issues about clinical evaluation of biosimilars. All speakers and attendees enjoyed this very stimulating and rewarding meeting, which gathered many people with divergent scientific backgrounds from the academic or industrial world.