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The article focuses on DelveInsight's "Cancer Monoclonal Antibodies Market Insights" report which showed that North America is anticipated to dominate the global cancer monoclonal antibodies market during the forecast period. Topics include notable monoclonal companies that are operating in the cancer monoclonal antibodies market and the emergence of sugemalimab as the world's first anti-PD-L1 monoclonal antibody approved for the first-line esophageal squamous cell carcinoma indication.

A recent report from researchers at the University of Coimbra in Portugal discusses the development and approval process of biosimilar medicines. Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions. These medicines are very similar to already approved biological medicines and go through a less extensive clinical study process, making them more affordable and accessible to patients. However, due to the complexity and variability of these products, it is important to have strict controls to ensure their safety and efficacy. The report focuses on the regulatory framework and approval requirements set by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for biosimilar medicines. [Extracted from the article]

A recent study conducted at Beth Israel Deaconess Medical Center in Boston, Massachusetts, explored the cost savings of combining dose rounding strategies (DRS) with the use of biosimilar products in oncology care. The study analyzed electronic health record data from two health systems in Rhode Island and found that combining DRS with biosimilar substitution for certain drugs resulted in significant cost savings per dose. The researchers recommend implementing this approach in healthcare systems to mitigate the rising costs of cancer care. The study was supported by the NIH National Institute on Aging. [Extracted from the article]

This article discusses the importance of the constant fragment (Fc) of the Immunoglobulin G1 (IgG1) subtype in the development of advanced therapeutics. Specifically, it focuses on the Fc region's role in N-glycosylation and its influence on protein stability. The study presents near-physiological temperature structures of the N-glycan-bound Fc fragment from a biosimilar VEGF-Trap, revealing alternate conformations within the glycan-binding pocket. Molecular dynamics simulations also highlight the structural plasticity of the Fc fragment. These findings provide valuable insights into the molecular basis of Fc-mediated functions and can inform the design of next-generation therapeutics. [Extracted from the article]

The US biosimilar market is projected to reach $71.04 billion by 2028, with a compound annual growth rate of 40.16% from 2024 to 2028. Factors contributing to market growth include the increasing prevalence of cancer, a growing geriatric population, and a favorable environment. However, the market may face challenges due to manufacturing complexities, intense competition, and pricing complexities. Monoclonal antibodies currently hold the largest share of the US biosimilar market, followed by filgrastim & pegfilgrastim. The report also provides insights into specific biosimilar products and their market landscape, as well as the impact of COVID-19 on the industry. [Extracted from the article]

This document provides information about a clinical trial for a biosimilar candidate called FYB206, which is being tested as a potential treatment for cutaneous melanoma. The trial involves administering FYB206 or Keytruda, a currently approved drug, to patients with Stage IIB, IIC, or III melanoma who have undergone complete resection. The trial is currently recruiting participants, with a target enrollment of 94 patients, and is expected to be completed by June 30, 2026. The study is being conducted in Moldova, Republic of. The document also includes administrative information about the trial, such as the NCT number and study ID numbers. [Extracted from the article]

A new study conducted in Osaka, Japan, evaluated the one-year outcomes of intravitreal ranibizumab biosimilar (RBZ-BS) injections for myopic choroidal neovascularization (mCNV) in Japanese patients. The study included 21 patients with high myopia and mCNV, with 12 being treatment-naive and 9 having previous anti-VEGF treatments. The results showed that RBZ-BS was effective and safe in treating mCNV, particularly in treatment-naive patients. The use of RBZ-BS was also found to be a cost-effective alternative to the original ranibizumab. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these findings. [Extracted from the article]

The article focuses on a University of Illinois researcher's advice to the US Food and Drug Administration (FDA) to permit the US Pharmacopeia (USP) to create Biological Product Specifications (BPS) for biosimilars. Topics include the elimination of side-by-side analytical comparisons with reference products, the role of BPS in establishing global quality standards, and the potential impact on biosimilar affordability and interchangeability.

A recent study conducted by researchers at Kaiser Permanente compared the clinical outcomes of two filgrastim biosimilars, filgrastim-aafi and filgrastim-sndz, in patients with select solid tumors receiving myelosuppressive chemotherapy. The study found that the outcomes of severe neutropenia were comparable between the two biosimilars. The findings suggest that different filgrastim biosimilars can be utilized in clinical practice. This research provides valuable information for healthcare professionals and patients considering these treatments. [Extracted from the article]

This document provides information about a clinical trial, with the identifier NCT06530251, that is currently being conducted in China. The trial aims to evaluate the safety and effectiveness of AK112, a PD-1/VEGF bispecific antibody, in combination therapy for patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer. The trial consists of two parts: a phase Ib trial to determine the maximum tolerable dose and recommended phase 2 dose of AK112, and a phase II trial to compare the safety and efficacy of AK112 in combination therapy or monotherapy with other drug combinations. The trial is expected to be completed by June 2026 and aims to enroll 280 participants who have not received previous anti-tumor treatment. [Extracted from the article]

A recent study conducted at Shanghai University focused on the therapeutic effect and mechanisms of ABP501, an adalimumab biosimilar, in rheumatoid arthritis (RA). Adalimumab is a widely used antibody that inhibits the biological activity of TNF-a, a protein involved in inflammation. The study found that there are small differences in side effects and clinical reactions between reference drugs and similar drugs. The launch of adalimumab biosimilars provides more choices for patients with RA, but it is important to use actual data to ensure correctness and safety. [Extracted from the article]

This document, titled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers," provides guidance from the U.S. Food and Drug Administration (FDA) on manufacturing changes made to licensed biosimilars and interchangeable biosimilars. The guidance aims to inform applicants and interested parties about the information that should be provided to support manufacturing changes in different reporting categories. The document includes keywords such as FDA, biotechnology, business, biologics, biosimilars, bioengineering, drugs and therapies, genetic engineering, health and medicine, genetically-engineered proteins, and government agencies. [Extracted from the article]

According to a research report by Fact.MR, the global biosimilar market is projected to reach a size of $43.8 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 8.9% from 2024 to 2034. Biosimilars are gaining popularity as cost-effective alternatives to expensive biologic medications, with equivalent efficacy, safety, and affordability. They have the potential to treat various conditions such as diabetes, autoimmune disorders, and cancer, improving patient access to life-changing therapies. As regulatory frameworks evolve and acceptance increases, biosimilars are expected to become integral to long-term healthcare strategies, fostering competition and ensuring broader access to advanced treatments. [Extracted from the article]

A recent report from researchers at Duke University explores the potential for biosimilar competition in the field of cell and gene therapies (CGTs). The report discusses the challenges of achieving regulatory requirements for biosimilarity in CGTs, including manufacturing complexities and the need for standardized platforms. Intellectual property barriers and market size limitations are also identified as potential obstacles to the adoption of biosimilars in this field. The research suggests that gene therapies may be more suitable candidates for biosimilar development compared to cell therapies. [Extracted from the article]

This document provides information about a phase III study comparing the effectiveness, safety, and immunogenicity of two drugs, GNR-086 and Ilaris(R), in treating Still's Disease Adult Onset. The study included 148 patients who received a subcutaneous dose of either GNR-086 or Ilaris(R) every four weeks for 24 weeks. The study design was randomized and the primary purpose was treatment. The recruitment for the study is currently not active, and the completion date is projected to be December 31, 2025. The study is being conducted in the Russian Federation. [Extracted from the article]

A study conducted by researchers at Jordan University of Science and Technology explores the challenges of developing biosimilars for antiangiogenic ophthalmic agents, specifically focusing on ranibizumab. Monoclonal antibodies and their derivatives, such as Fragment antigen binding proteins, have revolutionized treatment options for various conditions. However, the replication of these complex molecules is difficult, and the introduction of biosimilars without comprehensive evidence of comparability to the originator drug poses potential risks for patients. The review aims to provide pharmaceutical professionals and regulatory officers with essential technical requirements for conducting a comprehensive comparability exercise for ranibizumab biosimilars, ensuring that the biosimilar product aligns with stringent quality standards. [Extracted from the article]

A study conducted by Harvard University has found that there is a significant difference in the coverage of biosimilars and their reference biologics between Medicare Part D and employer-sponsored health insurance plans. This difference may be due to the design elements of Part D plans that encourage the use of more expensive biologic drugs. The study suggests that if Part D formularies resembled those of employer-sponsored plans, Medicare patients and the federal government could save a substantial amount of money. The research predicts that the Inflation Reduction Act of 2022 will also have a positive effect on biosimilar coverage. [Extracted from the article]

A recent study conducted by the Doheny Eye Institute in Pasadena, California, explores the use of biosimilars as a cost-effective alternative to branded agents for treating ophthalmic diseases. The study highlights the potential benefits of biosimilars, which have been shown to be clinically equivalent to reference products. Specifically, the study focuses on anti-vascular endothelial growth factor (VEGF) biosimilars and discusses the regulatory and scientific concepts surrounding their development, as well as the challenges and opportunities associated with their uptake in ophthalmology. This research has been peer-reviewed and provides valuable insights for healthcare systems and patients seeking affordable treatment options. [Extracted from the article]

This document provides information about a clinical trial, NCT06504966, that is currently underway to compare the effectiveness and safety of two drugs, MAB-22 and Prolia(R), in postmenopausal women with osteoporosis. The trial aims to demonstrate that MAB-22 is similar and not inferior to Prolia(R) in terms of bone density and collagen levels. The study is still in the recruitment phase and is expected to be completed by October 2026. The trial is being conducted by Xentria, Inc. and is regulated by the U.S. FDA. [Extracted from the article]

According to a report by Transparency Market Research, the global injectable drug delivery system market is projected to reach USD 1.9 trillion by 2034, with a compound annual growth rate (CAGR) of 9.8%. The increasing prevalence of chronic diseases and infectious diseases is driving the demand for drugs and medical assistance, leading to a higher demand for appropriate drug delivery systems. The rising preference for minimally invasive therapies and treatments is also contributing to the demand for injectable drug delivery systems. Technological advancements, such as AI and IoT, are further enhancing the precision and effectiveness of drug delivery. The market is segmented based on product type, therapeutic applications, and usage patterns. [Extracted from the article]

GCCL, a clinical trial sample analysis institution, has developed pharmacokinetic (PK) analysis methods for biosimilars of blockbuster drugs and offers customized clinical trial analysis services. The company has established a new R&D division that specializes in biomarker research and development. GCCL has focused on biosimilars as its first area of specialization and has completed the development of PK analysis methods for drugs such as Keytruda and Yervoy. The company aims to proactively develop and validate analysis methods for developers, enabling swift clinical trial analysis. GCCL is also conducting research on analysis methods for breast cancer treatment using equipment such as ELISA and ddPCR. The company recently introduced ddPCR equipment to enhance clinical trial analysis for cell and gene therapies. CEO Yang Song-hyun stated that GCCL will continue to enhance its clinical sample analysis services and R&D capabilities for various therapeutics. [Extracted from the article]

Boehringer Ingelheim and GoodRx have partnered to offer a patient affordability initiative for Adalimumab-adbm, Boehringer's biosimilar to Humira. Adalimumab-adbm is an FDA-approved interchangeable biosimilar used to treat autoimmune conditions. Through this initiative, patients with a valid prescription can purchase Adalimumab-adbm at a low cash price exclusively on GoodRx, regardless of insurance status. The program aims to address access and affordability issues in the therapeutic category and improve patient access to critical treatments. The exclusive cost for Adalimumab-adbm is $550 per two-pack, representing a 92% discount from the Humira list price. [Extracted from the article]

This document provides information about a clinical trial for a drug called tocilizumab, also known as Actemra. The trial is comparing Actemra to a biosimilar called Complarate. The trial is currently recruiting participants and aims to enroll 256 individuals. The study is being conducted in Russia and is open to both men and women between the ages of 18 and 45. The trial has specific eligibility criteria, and interested individuals can contact the primary investigator for more information. The document also includes administrative information about the trial, such as the NCT number and the study chair. [Extracted from the article]

This document provides information about a phase 2 clinical trial, NCT06495125, that is investigating the effectiveness of a combination treatment for patients with LKB1-mutant non-small cell lung cancer. The trial aims to determine the efficacy of defactinib and avutometinib, kinase inhibitors, when combined with nivolumab, a monoclonal antibody. The trial will evaluate response rate, overall survival, and toxicity, and will include biomarker evaluation. The document also includes a list of medical terms and procedures related to cancer treatment, such as biopsy, biospecimen collection, computed tomography, positron emission tomography (PET), and PET scan. The trial is not yet recruiting and will enroll 50 patients with non-small cell lung cancer. It is being conducted at Emory University and is sponsored by the National Cancer Institute. [Extracted from the article]

A study conducted by Northwestern University explores the obstacles to the acceptance and uptake of biosimilar drugs in oncology. Biosimilars are cost-effective replicas of target drugs, but their commercialization has been limited since the approval of the first biosimilar drug in 2015. The study identifies both economic and noneconomic factors that contribute to the slow adoption of biosimilars, including a lack of healthcare professional education, concerns about safety and efficacy, and complex product naming systems. The researchers emphasize the need to address these barriers in order to maximize the potential of biosimilar drugs in reducing treatment costs and increasing patient access. [Extracted from the article]

A recent report from the University of North Carolina discusses the use of infliximab biosimilars in rheumatology and gastroenterology clinics. The study found that clinical trials comparing these biosimilars with the originator product have consistently shown noninferiority and similar adverse effect profiles. The university conducted an initiative to convert patients from the originator infliximab product to biosimilar agents based on market costs, and a retrospective evaluation was conducted to analyze the outcomes of these patients. The research concluded that converting clinically stable patients to biosimilar products resulted in a significant increase in biosimilar use without sacrificing overall clinical control, providing financial advantages to both the institution and patients. [Extracted from the article]

A study conducted by Johns Hopkins University examined the uptake of biosimilar drugs in Medicare Advantage (MA) and Traditional Medicare from 2016 to 2019. The study found that there was consistently greater uptake of filgrastim and infliximab biosimilars in MA compared to Traditional Medicare. By the end of 2019, the uptake of filgrastim biosimilars was 7.6 percentage points higher in MA than Traditional Medicare, and the uptake of infliximab biosimilars was 28.7% in MA and 15.4% in Traditional Medicare. The study suggests that MA Kaiser HMO plans were primarily responsible for the higher uptake of biosimilars in MA. Further research is needed to examine the specific strategies employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake. [Extracted from the article]

Altos Biologics, a subsidiary of Alteogen Inc., has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar called ALT-L9. The application follows a Phase 3 clinical trial involving over 400 subjects across 12 countries, which demonstrated therapeutic equivalence between ALT-L9 and Eylea(R) in the treatment of wet Age-related Macular Degeneration. Altos Biologics expects to receive approval from the EMA by 2025 and plans to negotiate License Agreements with potential distributors worldwide. The company also aims to develop a novel multi-specific fusion protein therapeutic for ophthalmic diseases. [Extracted from the article]

A patent application has been filed for a therapeutic combination of a CD19 inhibitor and a BTK inhibitor for the treatment of various types of cancers, as well as inflammatory, immune, and autoimmune disorders. The combination of these inhibitors has shown effectiveness in treating hyperproliferative diseases. The patent application also suggests that the combination of an anti-CD20 antibody with the CD19 and BTK inhibitors may be effective in treating these diseases. The patent application describes a method of treating hyperproliferative diseases, particularly cancer, by co-administering a CD19 inhibitor and a BTK inhibitor, and also includes the use of gemcitabine or albumin-bound paclitaxel in combination with the inhibitors. The invention encompasses the use of specific cancers, inhibitors, and additional therapies in combination with the CD19 and BTK inhibitors. [Extracted from the article]

A study conducted by researchers at the University of Texas Austin examined the perceptions and barriers to the utilization of biosimilars in community oncology practices. The study found that biosimilars can reduce costs and increase access to life-saving care, but their uptake in the US has been inconsistent. The research surveyed 400 healthcare professionals and analyzed their responses, finding that perceived barriers to biosimilar utilization were not common and did not impact utilization rates. The study suggests that future research should consider other factors that may affect biosimilar utilization. [Extracted from the article]

Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new facility in Bengaluru, India. This approval will increase the company's capacity to meet the needs of patients in European markets. The EMA has also renewed the Good Manufacturing Practice (GMP) Certificates of Compliance for Biocon Biologics' manufacturing facilities in Bengaluru and Malaysia. These certifications demonstrate the company's commitment to quality and addressing patient needs globally. [Extracted from the article]

A recent study conducted by researchers at the University of California examined the impact of the World Health Organization's (WHO) 2022 guidelines on the evaluation of biosimilars for non-local comparators in biosimilar studies. The study found that the WHO guidelines have been integral to the regulatory framework of over a dozen countries in the Middle East and North Africa region for more than a decade. However, many of these countries have been hesitant to source comparator products outside of the US or European countries, which has resulted in slow regional development and cooperation in the biosimilars market. The researchers suggest that future studies are needed to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms. [Extracted from the article]

A study conducted in Murcia, Spain compared the effectiveness, drug survival, and pharmacokinetic profiles of the biosimilar infliximab (CT-P13) and the reference infliximab (IFX) in patients with inflammatory bowel disease (IBD). The study found that both drugs had comparable efficacy, drug survival, pharmacokinetic profiles, and incidence of immunogenicity in a real clinical setting. However, further studies with greater statistical power are needed to validate these findings. This research has been peer-reviewed and published in Gastroenterologia y Hepatologia. [Extracted from the article]

A recent study conducted at Hangzhou Medical College in China aimed to evaluate the bioequivalence of two formulations of rupatadine, a drug used for allergies, in healthy Chinese subjects. The study found that the test drug, rupatadine fumarate, showed a similar safety profile to the reference drug, Wystamm, and its pharmacokinetic bioequivalence was confirmed in both fasting and postprandial conditions. The study was supported by various medical and health research programs in Zhejiang Province. The findings provide new insights into biosimilars and their potential use in Chinese populations. [Extracted from the article]

A recent study conducted by the University of Manchester in the United Kingdom examined the outcomes of switching children and young people with juvenile idiopathic arthritis (JIA) from biological originator drugs to biosimilars. The study found that there was no evidence to suggest that patients who switched to biosimilars were more likely to stop treatment compared to those who continued with the originator drugs. Additionally, disease activity was similar between the two groups, indicating that non-medical switching was well-tolerated in this patient population. The findings provide reassurance to clinicians and patients regarding the effects of non-medical biological switching. [Extracted from the article]

A new report from the U.S. Oncology Network highlights the potential cost-saving benefits of biosimilars in healthcare. The study analyzed Medicare reimbursement rates for reference agents and their biosimilars over a period of 2 years before and 5 years after launch. The research found that biosimilars had lower reimbursement rates at launch and experienced a faster decline in price compared to reference agents. This competition from biosimilars contributed to a decrease in reimbursement for reference agents, ultimately driving down healthcare costs. The study also noted that factors such as manufacturer rebates, payer policies, and discounts on reimbursement are areas of ongoing investigation. [Extracted from the article]

A recent report from the Department of Medical Oncology discusses the treatment of HER2-positive metastatic breast cancer (mBC) in India using a biosimilar called T-DM1. The study involved 16 patients with HER2-positive mBC and aimed to assess the effectiveness and safety of T-DM1. The study found that T-DM1 had an overall response rate of 81.3%, with one patient achieving complete response and 12 patients achieving partial response. The most common adverse events were thrombocytopenia and anemia. The study concludes that T-DM1 biosimilar is a safe and effective treatment option for HER2-positive mBC in India. [Extracted from the article]

A recent report from Northwestern University Feinberg School of Medicine discusses the obstacles to the acceptance and uptake of biosimilars in oncology. Biosimilar drugs are cost-effective replicas of target drugs, but their commercialization has been limited since the approval of the first biosimilar drug in 2015. The review highlights psychological, attitudinal, and educational factors that contribute to the slow adoption of biosimilars, including a lack of healthcare professional education, concerns about safety and efficacy, and complex product naming systems. To fully realize the potential of biosimilars in reducing treatment costs and increasing patient access, both economic and noneconomic factors need to be addressed. [Extracted from the article]

A recent study conducted by researchers at the University of Manchester in the United Kingdom explored the potential for altering dosing intervals of biosimilars to adalimumab and etanercept in patients with rheumatoid arthritis (RA). The study aimed to determine if adjusting the dosing intervals could achieve therapeutic drug levels more quickly or similarly to the recommended interval. The researchers recruited RA patients starting the adalimumab and etanercept biosimilars and analyzed their drug levels using population pharmacokinetic analysis. They found that simulations of altered dosing intervals could potentially lead to personalized dosing studies in the future, which could increase efficacy and potentially save costs. [Extracted from the article]

A recent study conducted by researchers at IRCCS San Raffaele Hospital in Milan, Italy, explored the benefits of using biosimilars in the management of patients with inflammatory bowel disease (IBD). The study found that biosimilars, which are less expensive versions of biologic drugs, were widely available and had a reduced cost compared to the original drugs. The cost savings from using biosimilars allowed physicians to improve patient care or conduct research in some cases. However, the availability of biosimilars did not significantly influence treatment decisions for most participants. The impact of biosimilars on access to therapies and treatment algorithms for IBD remains to be determined. [Extracted from the article]

A recent study conducted at Tver State Medical University in Russia examined the use of the biosimilar insulin RinFast(R) in children with type 1 diabetes mellitus (DM1). The study evaluated the efficacy and safety of RinFast(R) as bolus therapy in combination with long-acting insulin and as monotherapy in an insulin pump. The results showed that there was no clinically significant deterioration in glycemic control after switching to RinFast(R), indicating that it can be used safely and effectively in children with DM1. The study highlights the need for more research on the use of biosimilar insulin in this population. [Extracted from the article]

A recent study investigated the potential interaction between lecanemab, a therapeutic antibody used in Alzheimer's disease treatment, and plasma proteins in the bloodstream. The study found that lecanemab binds to fibrinogen, a plasma protein, although with lower affinity than to amyloid beta. This suggests that fibrinogen levels could impact the levels of free antibodies in the bloodstream and that fibrinogen may serve as a reservoir for lecanemab. The findings highlight the importance of considering plasma protein binding when using therapeutic antibodies in neurodegenerative diseases. [Extracted from the article]

The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates. The FDA approved the 50th biosimilar, expanding patient access to treatments for chronic and severe illnesses. They have also finalized guidance for the veterinary feed regulations and approved the first generic pimobendan for congestive heart failure in dogs. The FDA issued a warning letter regarding the sale of unauthorized plastic syringes made in China and provided an update on their evaluation of these syringes. Additionally, the FDA posted reports on the performance of drugs and biologics firms in conducting postmarketing requirements and commitments, and they approved lutetium Lu 177 dotatate for pediatric patients with neuroendocrine tumors and tovorafenib for pediatric patients with low-grade glioma. [Extracted from the article]

This document provides information about a clinical trial, NCT06393751, that is investigating the effectiveness of a treatment regimen for high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. The trial involves the use of bevacizumab, paclitaxel, and tolinapant, administered through intravenous and oral routes. The study aims to evaluate the efficacy and safety of this treatment regimen in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer. The trial is not yet recruiting participants, and the estimated completion date is February 9, 2028. The document also includes eligibility criteria for potential participants. [Extracted from the article]

A study conducted at Sophia Children's University Hospital in Rotterdam, Netherlands, examined the cost-effectiveness of first-line infliximab treatment compared to conventional treatment in children with moderate-to-severe Crohn's disease. The study included 89 patients and found that first-line infliximab treatment resulted in higher odds of being in clinical remission without being more expensive. This makes it the dominant strategy for the first two years after diagnosis in children with moderate-to-severe Crohn's disease. The research was supported by Pfizer and has been peer-reviewed. [Extracted from the article]

Henlius Biotech, Inc. has announced that its business partner, Accord BioPharma Inc., has received approval from the United States Food and Drug Administration (FDA) for HERCESSI (HLX02), a trastuzumab biosimilar developed and manufactured by Henlius. The product has been approved in the United States for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 has also been approved in more than 40 countries and regions, including China, the European Union, and the United Kingdom, and has benefited over 180,000 patients. [Extracted from the article]

A new report published by researchers at King Saud Bin Abdulaziz University for Health Sciences in Saudi Arabia examines the practice of substituting generic drugs, specifically biosimilars, for brand-name drugs. The report highlights concerns regarding the bioequivalence and therapeutic equivalence of generic drugs, particularly in the case of rare diseases and certain patient populations such as children and the elderly. The researchers emphasize the need for refining regulatory frameworks for generic substitution, with a focus on Saudi Arabia. The report provides a critical analysis of global practices and offers insights into the perspective of Saudi Arabia on this issue. [Extracted from the article]

A study conducted by the University of Belgrade examined the factors associated with hematological adverse drug reactions (HADRs) caused by drugs authorized by the European Medicines Agency (EMA) up to July 2023. The study found that 54.78% of proprietary drugs were associated with HADRs, with anemia, leucopenia, and thrombocytopenia being the most common reactions. The research identified generic status, biosimilar status, and inclusion on the Essential Medicines List (EML) as predictors of HADRs, while the administration route was found to be a protective factor. The study suggests that understanding these regulatory factors can help clinicians monitor patients when new drugs are introduced. [Extracted from the article]