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. A number of factors facilitate the development and uptake of Biosimilars in India. Poor patent enforcement in India provides opportunities for domestic biologics manufacturers, while publicprivate sector partnerships promote biologics development. Since there are less stringent regulatory requirements and low R&D costs, domestic biologics are priced much lower in India compared to originators, further driving uptake, as well as offering huge potential for contract manufacturing of biosimilars and for exports. Domestic companies are also entering into partnerships to facilitate development of biologics for the Indian and global market. However, despite the low price of Biosimilars compared to originator brands, the domestic market is restricted by limited health insurance coverage and therefore poor access to biologic drugs. Also, issues regarding the quality and safety of some domestically manufactured biologics remain a concern among patients and physicians.