Journal of Clinical & Experimental Pharmacology

Regulatory and quality requirement for US biosimilar product development

Co-organized Event International Conference on Toxicology and Clinical Pharmacology & 2^nd International Conference on Generic Drugs and Biosimilars

December 14-16, 2017 Rome, Italy

Audrey Jia

DataRevive LLC, USA

Posters & Accepted Abstracts: Clin Exp Pharmacol

Abstract:

Biosimilar development is relatively new in the US when compared to EU. The off-patent blockbuster biologics inspired many biosimilar products developments in the US. The quality and safety requirement for biosimilar approval is still in the process of developing by the regulatory authorities. Both the agency and the industries are learning through studying, reviewing and using biosimilars. Different from structurally well-defined, low molecular weight chemical drugs, biologic products are complex molecules that are generated from live cells such as bacteria, yeast, or mammalian cells. Most of them carry post translational modifications (PTM), and have inherited heterogeneity. They often contain multiple units/domains and have multiple functions and complicated mechanism of actions (MoA). Their manufacturing processes are also more complicated than synthetic small molecules. In addition, biological products often have immunogenicity issues when used in patients. Beyond these, the biosimilar developers probably need to use different cell expression system, raw materials, process, purification platform, and different formulation during the biosimilar product development. With such a complex molecule and so many unpredictable manufacturing difference, the company needs to demonstrate that the biosimilar product is highly like the reference product. And such demonstration is also controlled and limited by the knowledge of the variation of the reference products. All these factors make biosimilar product development a challenging task. This talk will focus on the regulatory landscape of biosimilar development in the US and CMC requirement for analytical similarity assessment to support the biosimilar product development