India, Jan. 31 -- image credit- shutterstock

Current Bisosimilars landscape in India

India's biosimilars landscape is at an advanced and rapidly scaling stage, with the country emerging as one of the world's most active biosimilar hubs. By December 2025, India had approved a total of 146 biosimilar (recombinant therapeutic products), including insulins, growth factors, peptide hormones, fusion proteins, and monoclonal antibodies.

India initiated the development and regulatory approval of recombinant therapeutics considerably earlier than many emerging markets, with the first approvals appearing as early as 2000. However, biosimilar activity remained limited during the initial decade, largely confined to relatively simple recombinant pr...