Complex Peptide Injectables: Development and Challenges

International Journal of Peptide Research and Therapeutics, Journal Year: 2025, Volume and Issue: 31(3)

Published: March 13, 2025

Language: Английский

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A Regulatory Perspective on Biosimilar Medicines

Pharmaceutics, Journal Year: 2024, Volume and Issue: 16(3), P. 321 - 321

Published: Feb. 25, 2024

By definition, biosimilar medicinal products are biological that similar to other already on the market-the reference products. Access medicines is a current reality. However, achieve this goal, it extremely important consistently and scientifically substantiate regulatory requirements necessary for when accessing market. Based an analysis of raw materials type methods used in manufacturing processes medicines, known tends be more complex quality finished product than manufacture molecules obtained through chemical process. It then relevant highlight main differences between both products: manufactured using biotechnology generics containing active pharmaceutical ingredients (APIs) from synthetic processes. Once arriving at approval process these products, imperative analyse guidance documents framework create rules allow come The present review aimed documenting comparatively specific provisions European legislation, Medicines Agency (EMA), as well legislation United States America, Food Drug Administration (FDA). This was translated into critical appraisal what concerns criteria determine favourable evaluation application marketing authorisation submitted different agencies. gathered evidence suggests key success lies rigorous universal regulation greater knowledge, acceptance, awareness health professionals enable patients treated with strategies earlier stage disease affordable ensuring always safety efficacy those medicines.

Language: Английский

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Bridging the gap: The future of biosimilars regulations

Human Vaccines & Immunotherapeutics, Journal Year: 2024, Volume and Issue: 20(1)

Published: June 17, 2024

Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities regulations of biosimilar products across different nations. It also navigates benefits global regulatory alignment challenges that may be encountered. The discrepancies countries, which pose significant for development approval products. These often lead to delayed market access, increased costs, hindered innovation. stresses such obstacles could mitigated through harmonized regulations, resulting faster approvals, reduced healthcare improved patient outcomes. Moreover, explores specific complexities associated with immunotherapeutic, as intricate evaluation biosimilarity due their molecular composition immunogenic properties. In conclusion, editorial advocates collaborative efforts overcome achieving harmonization biosimilars. includes establishing uniform standards, fostering international cooperation among agencies, promoting educational initiatives providers regulators. ultimate goal is ensure patients worldwide have timely access safe, effective, affordable treatments.

Language: Английский

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Cost–consequence analysis of early vs. delayed natalizumab use in highly active relapsing–remitting multiple sclerosis: a simulation study

Journal of Neurology, Journal Year: 2025, Volume and Issue: 272(2)

Published: Jan. 17, 2025

Abstract Background Natalizumab (NAT) is an established disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, its use involves complex decision-making, often leading to initial of lower efficacy therapies. Recently, the first biosimilar NAT was approved, enabling competitive pricing. This study assessed societal implications initiating in various scenarios through a cost–consequence analysis. Methods A 10-year Markov model based on Expanded Disability Status Scale (EDSS) employed, with 11 health states, annual cycles, and half-cycle correction. The cohort had age 36 years 70% females. compared common therapies (glatiramer acetate, teriflunomide, dimethyl fumarate, fingolimod). Scenarios included continuous use, early (after 1 year), delayed (5 years) switch NAT. Baseline characteristics probabilities clinical economic outcomes were derived from trial data, published literature, other available sources. Results Continuous resulted highest time spent low EDSS levels, fewer relapses, reduced life lost due disability, higher employment rate over period. Switching after year yielded similar use. Despite DMT costs, disease management including indirect costs non-DMT direct medical Late switching most comparable DMT. Conclusion better burden initiation, indicating potential long-term cost savings.

Language: Английский

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A Comprehensive Review of Evidence and Challenges in Switching from Originator Drugs to Biosimilars of Monoclonal Antibodies: Focus on Rituximab and Trastuzumab

Journal of Drug Delivery and Therapeutics, Journal Year: 2025, Volume and Issue: 15(2), P. 149 - 155

Published: Feb. 15, 2025

Objective: The primary objective of the document is to conduct a comprehensive review clinical, economic, and regulatory evidence regarding transition from originator drugs biosimilars monoclonal antibodies, focusing specifically on rituximab trastuzumab. aims analyze data biosimilar usage, assess barriers adoption, explore potential strategies overcome challenges, with ultimate goal improving healthcare sustainability accessibility. Data source Study selection: study selection includes clinical trials, economic analyses, reviews It focuses phase 3 cost-effectiveness studies, post-marketing surveillance for assessing safety, efficacy, adoption barriers. Real-world guidelines agencies such as EMA FDA are also considered. Summary: article antibody biosimilars, Topics evidence, benefits, include issues related immunogenicity concerns perceived physician-patient acceptance. While offering potentially cost-effective treatments cancer, further research, harmonization regulations, education will allow this value be realized across more patients, improved outcomes. Conclusion: like trastuzumab, enhances treatment accessibility affordability. Clinical supports their safety but challenges remain, including concerns, differences, stakeholder perceptions. Addressing these through global can optimize sustainability. Keywords: Rituximab, Trastuzumab, Biosimilars, Switching, Monoclonal Antibodies.

Language: Английский

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Regulatory and clinical aspects in biosimilar medicines: comparability, extrapolation, interchangeability, and safety

Drugs & Therapy Perspectives, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 27, 2025

Language: Английский

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Development of Complex Generics and Similar Biological Products: An Industrial Perspective of Reverse Engineering

AAPS PharmSciTech, Journal Year: 2025, Volume and Issue: 26(4)

Published: March 26, 2025

Language: Английский

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Fostering healthcare system sustainability through efficient practices: Can adopting biosimilars ease the financial burden of rheumatoid arthritis?

F1000Research, Journal Year: 2025, Volume and Issue: 13, P. 1128 - 1128

Published: April 4, 2025

Immune-mediated inflammatory diseases like rheumatoid arthritis (RA) have been successfully treated using biologic disease-modifying antirheumatic drugs. These medications are not utilized as first-line treatment, in part because of their high cost, but they frequently seen to be cost-effective for RA patient populations that do respond adequately conventional Moreover, all patients who meet clinical eligibility criteria can access biologics, even second-line therapy. Recently, there has an increasing interest biosimilars highly comparable originator biologics terms efficacy and safety generally come at a lower price. This review summarizes the potential role reducing expenditure therapies. As global landscape continues evolve, it is essential consider unique challenges opportunities different healthcare systems. By leveraging biosimilars, systems improve management, ease its economic burden ensure effective affordable treatments. The future treatment lies integration into practice, offering hope more sustainable equitable systems.

Language: Английский

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Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments

Pharmaceuticals, Journal Year: 2024, Volume and Issue: 17(7), P. 925 - 925

Published: July 10, 2024

This research is based on three fundamental aspects of successful biosimilar development in the challenging biopharmaceutical market. First, regulations eight selected countries: Japan, South Korea, United States, Canada, Brazil, Argentina, Australia, and Africa, represent four continents. The regulatory countries studied are analyzed, highlighting challenges facing biosimilars, including their complex approval processes need for standardized guidelines. There an inconsistency depending whether used a developed or developing country. In observed, biosimilars considered excellent alternatives to patent-protected biological products treatment chronic diseases. second aspect addressed, various analytical AI modeling methods (such as machine learning tools, reinforcement learning, supervised, unsupervised, deep tools) were analyzed observe patterns that lead prevalence cancer model behaviors most prominent active compounds with spectroscopy. Finally, analysis use approved by FDA EMA was proposed.

Language: Английский

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Comprehensive approaches to preclinical evaluation of monoclonal antibodies and their next-generation derivatives

Biochemical Pharmacology, Journal Year: 2024, Volume and Issue: 225, P. 116303 - 116303

Published: May 24, 2024

Language: Английский

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