"The biosimilar developers are eagerly awaiting revised CDSCO regulations that might lead to simplification of the development pathway for biosimilars"

How has India's biosimilars landscape evolved over the past 25 years, and what have been the most significant milestones?

- In an interaction with BioSpectrum, Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC)

Can you share insights into the number of biosimilars approved for domestic use vs. exports?

India approved its first biosimilar, Biovac-B for hepatitis B in 2000 which was launched by Wockhardt Limited. Since then, several biosimilars have been developed and marketed in India by various biopharmaceutical companies. Department of Biotechnology (DBT), India announced the release of regulatory guidelines for 'similar biologics' on 19 June 2012 and these guidelines were implemented on September 15, 2012. The guidelines outline a simple abridged procedure for evaluation of 'similar biologics' which have been approved and marketed in India, Europe or USA for more than four years. These guidelines were then revised and updated, with new guidelines, which came into effect in August 2016.

Apart from the streamlined regulations, DBT and its public sector enterprise Biotechnology Industry Research Assistance Council (BIRAC) have made sustained efforts through funding, policy advocacy, new initiatives, capacity building, and promoting innovation and infrastructure creation in research institutions, small and medium size companies, and large firms. The schemes of BIRAC like the Biotechnology Industry Partnership Program (BIPP), Small Business Innovation Research Initiative (SBIRI) and Promoting Academic Research Conversion to Enterprise (PACE) launched between 2008 and 2012 are to assist small and medium-sized biotech firms in the creation of biosimilars.

In 2017, the Government of India, DBT with co-funding from World Bank, launched the National Biopharma Mission (NBM), an Industry-Academia Collaborative Mission for accelerating discovery research to early development for Biopharmaceuticals, implemented by BIRAC. One of the focused mandates of the Mission is to accelerate the biosimilar development to bring them closer to market.