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25th International Congress on Pharmaceutical Biotechnology

Amsterdam, Netherlands

Priti J Mehta

Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Gujarat, India

Title: Biosimilars: Comparative evaluation of Regulatory requirements of selected countries


Biography: Priti J Mehta


In recent few years, there are many classic Biological products are going off patent which has generated an abridged route for the Biosimilars products which relies on the extensive comparability testing against Reference Biological Products (RBP). A biosimilar demonstrates similarity to the reference biotherapeutics product in terms of quality, safety and efficacy.  Biosimilars are product similar to biologics but not identical.

The generic approach (demonstration of bioequivalence with a reference medicinal product by appropriate BABE studies) which used for most small molecule drugs is in principle not appropriate to biological/biotechnology derived products due to their complexity.

For approval of a biosimilar product, guidelines in various countries provide abbreviated approval pathway involving step-wise comparability exercise of a biosimilar with reference biological product which requires the generation of comparative analytical, non-clinical and clinical data (usually one or two phase I and phase 3 comparative studies). The scientific principles of such a biosimilar comparability exercise are based on those applied for evaluation of the impact of changes in manufacturing process of a biological medicinal product. The amount of data required for biosimilar approval is more than that for generic small molecule chemical product approval and less than that for reference biological product.

EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in USA (2009), Brazil (2010), India (2012) and in China (2015). This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, USA, Brazil, and China.