India, April 30 -- image credit- shutterstock

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