Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Over
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Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview
Therapeutic Innovation & Regulatory Science 1-13 ª The Author(s) 2020 https://doi.org/10.1007/s43441-020-00112-8
Atul Sharma, MPharm1, Shyam Khante, MPharm1, Kakasaheb R. Mahadik, MPharm, PhD2, and Vinod L. Gaikwad, MPharm, PhD3
Abstract Biopharmaceutical medicines are complex molecules obtained from a living organism (plant or animal cells) and may contain components of a living organism using biotechnology. Biosimilars are closely similar to already approved biopharmaceutical products that could form a new generation of medicines that are available widely at an affordable cost. The expiry of patent and data protection of Remicade (infliximab) aggravated biosimilar acceptance in the open market. Analysis of data package submitted for infliximab biosimilar and assessment reports published by agencies shows the importance of European Medicines Agency (EMA) product-specific guidelines (monoclonal antibodies) that are being followed by different regulatory agencies worldwide. Considering utilization of case-by-case basis for biosimilar development, infliximab biosimilar product evaluation assessment report suggests similarity in nature and extent of data required in analytical, nonclinical, and clinical studies even on utilizing cell lines different from the reference product’s. Specific additional clinical study (phase III) is required for a biosimilar to be authorized by the Ministry of Health, Labour and Welfare (MHLW). US Food and Drug Administration and EMA widely accept the concept of extrapolation to other indications approved for the reference product. However, the Ministry of Health, Labour and Welfare, Japan shows a conservative approach for extrapolation to other indications in the absence of direct or indirect safety and efficacy data. Keywords Biosimilar, biologic, monoclonal antibody, regulation, USFDA
Introduction Biological medicines have been available for more than 2 decades for treating rare and severe diseases in various categories (ie, cancer, heart attack, stroke, multiple sclerosis, diabetes, rheumatoid arthritis, and autoimmune diseases). Biological medicines have been making up a major share of the global pharmaceutical market because of their rapidly rising health cost, whereas recombinant monoclonal antibody contributes to the largest segment (by revenue) in the biopharmaceutical industry.1,2 Many top-selling biological medicines have gone off patent or their patents are about to expire in the near future, which represents great opportunity for development of biosimilars in the pharmaceutical industry (Table 1). Biosimilars closely match the reference product already approved in the region and has insignificant differences with regard to its quality, safety, and efficacy and can act as an alternative for high-cost biological medicines that is available at an affordable price. Similar biological products are termed biosimilar, follow-on-biologics, bio-generics, or s
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