Biosimilars: Comparative evaluation of Regulatory requirements of selected countries

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. Analytical and non-clinical data requirement are similar across countries. Since local participation is required in all countries, so Phase III trial should be global and multi-centric. There is a need to develop a robust post-marketing surveillance plan to allay safety/immunogenicity concerns promising therapeutic approach for liver fibrosis.

Author(s): Priti J Mehta

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