Biosimilars and Regulations: A Review

Currently, all biologics in India, including innovative and bioequivalent biologics (also known as similar biologics in India), are approved as new drugs. Recently in 2012, the Department of Biotechnology (DBT) and Central Drugs Standard Control Organization (CDSCO) issued the “guidelines on similar biologics”. The guidance outlined an abridged procedure for the regulatory requirements for marketing authorization of similar biologics in India. Due to limited R&D capabilities, most domestic companies manufacture simple biologics. However, companies have increasingly begun to shift their focus to the development of both novel and copy versions of monoclonal antibodies and second-generation biologics, which though more expensive and complex to develop can be priced at a premium, and compete in a much less crowded market than that faced by first-generation biologics.

SOURCE: Malipatil NB, Haridas KM, Shruthi DP. Biosimilars and regulations: A review. J Pharm Biomed Sci. 2015; 05(06):453-468. Available at www.jpbms.info