Abstract

REGULATORY GUIDELINES FOR APPROVAL OF BIOSIMILARS IN INDIA, UNITED STATES AND EUROPE - A COMPREHENSIVE SUMMARY

Sai Sarvani Piratla* and Pooja Agarwal

ABSTRACT

A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products, follow-on protein products and subsequent-entry biologics. EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in 2012 in India. The United States enacted the Biologics Price Competition and Innovation Act (BPCI) in the end of March 2010 to providing an application pathway for follow-on biological products under sections 7001 to 7003 of the Patient Protection and Affordable Care Act and also codified in 42 USC 262(k). In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. In India, Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC) of Central Drugs Standard Control Organization (CDSCO) is responsible for the development and preclinical evaluation of recombinant biologics drugs. This article having precise, concise, and simple comparison of US, Europe and India related to biosimilar drugs regulations and litigation.

Keywords: Biosimilars, CDSCO, USFDA, EMA, Regulations, Litigation.