146 Biosimilars in 25 Years: India at Global Scale

Biosimilars are an important part of modern therapeutics and a central component of India's shift beyond a generics-led pharmaceutical model.

- Ayesha Siddiqui

As of December 2025, India has approved 146 biosimilars, giving it one of the largest and most diverse biosimilar portfolios globally. This portfolio has been built by around 33 companies actively engaged in biosimilar development and manufacturing. The Indian biosimilars market was valued at approximately Rs 4.37 billion in 2024 and is expected to grow at a compound annual growth rate of 14.2 per cent, reaching around Rs 16.49 billion by 2034, according to Expert Market Research. Policy initiatives, closer regulatory alignment with global standards, and a growing emphasis on exports are reinforcing biosimilars as a core pillar of India's evolving pharmaceutical landscape. Let's look at the current biosimilars landscape in India and how it is evolving.

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 proteins such as erythropoietin, granulocyte colony-stimulating factors, insulin, and follicle-stimulating hormone.

A gradual transition toward more complex biologics began after 2013, marked by the approval of India's first biosimilar monoclonal antibodies, including rituximab, trastuzumab, and infliximab.