Biosimilars in India 2025 Market Trends, Growth Forecast & Opportunities

Biosimilar market in India is poised to boom in 2025, due to increasing rates of chronic diseases, patent expiration, and also a favorable policy environment. Within the domestic revenue, the biosimilars portion grew from roughly USD 866 million in 2024 to an estimate of USD 1.5 billion in 2025 with a projected annual growth rate of roughly 19.9 percent CAGR through 2033.

Biosimilar is a term used to denote high similarity to a previously approved biological medicine called a reference product. Unlike generic small-molecule drugs, these complex molecules are made from living organisms, requiring extensive analytical and clinical studies to ensure there are no differences in safety and efficiency. India has a strong biosimilar ecosystem that has enabled Indian pharma companies to be the largest biosimilars market in the world. The US and Europe were not only behind India but also slower than them in licensing their first biosimilars. In 2000, India’s first biosimilar for hepatitis B was licensed and marketed, even in the absence of specific guidelines for the research and marketing of biosimilars in India.

India has secured its place in the global biopharmaceutical market and is anticipated to be the sixth-largest pharmaceutical market globally by 2030. In addition, biosimilar pharma companies in India are expanding the global market. Bio-networking, a type of biosimilar, has a compound annual growth rate of 30 percent, according to a 2017 report by the Associated Chambers of Commerce of India. Government reforms-such as solidifying strict quality regulations are contributing to improved manufacturing standards and controls in order to attain stringent quality standards and global equivalency. Countries where they manufacture have now increased their rankings in the generation of monoclonal antibodies, insulins, and vaccines because of cost competitiveness and also having an export option.

Biosimilar Partnerships and Licensing Deals in India

In 2025, biosimilar partnerships and licensing deals in India are driving market growth, with firms like Dr. Reddy’s and Biocon collaborating globally. Biosimilar pricing strategy in India focuses on affordability, offering products up to 40 percent cheaper than originators.

“India is rapidly establishing itself as a leading hub for biologics and biosimilars… We believe biosimilars are the future, but they will go through a painful period of slow acceptance. National healthcare systems must seriously begin to address the escalating costs of prescription drugs,” says Kiran Mazumdar Shaw, Chairperson  & MD, Biocon.

Biosimilar drugs in India and market is predicted to double in 2025, along with the extra potential for development in the treatment for oncology treatments as well as for autoimmune diseases makes for a good opportunity for organizational growth in biosimilars. Latest trends in Indian biosimilar manufacturing include, digital twins, advanced analytics, continuous bioprocessing, big data use, AI, cell line engineering, and personalized precision health which are followed by the partnered companies. CDSCO biosimilar guidelines, and originally issued in 2012 and revised in 2016, are being updated in 2025 to align with global standards and licensing deals in India.

Domestic vs MNC Biosimilar Companies in India

Domestic biosimilar companies in India are represented by Biocon, Intas, and Zydus which excel at minimizing development cost and accessing the local market. Futhermore, Biocon and Zydus are certainly in the lead in developing the biosimilar drugs and effectively getting them approved and marketed in the Indian pharmaceutical market. MNCs such as Roche and Pfizer work with Indian companies to take advantage of their regulatory and manufacturing agility to build their biosimilars business using collaborative partners.

Biosimilars 2025 forecast is expected to develop significantly due to factors like growing healthcare demands, the incidence of chronic illnesses, and a high desire for reasonably priced biologics. Biosimilars growth India is emerging as a major global center for the research and production of biosimilars because to government assistance through programs like "Make in India" and simplified regulatory processes. The market is anticipated to expand, providing substantial prospects for both domestic firms and global collaborations. Demand will be fueled by important therapeutic areas like diabetes, autoimmune diseases, and oncology and market expansion will be further accelerated by investments in R&D and infrastructure. CDSCO biosimilar guidelines, originally issued in 2012 and revised in 2016, are being updated in 2025 to align with global standards.

Also Read: Alembic Gets USFDA Nod for Cancer Drug in Single-Dose Vials

The rise of a prospective biosimilars industry in India is evident through the collaborations that well-known pharmaceutical companies from around the world are forming with Indian pharmaceutical enterprises. For example, the Indian company Emcure has entered into a marketing arrangement with the Swiss pharmaceutical company Roche to sell the cancer treatment medication Biceltis. Similarly, Biocon, a pharmaceutical company based in Bangalore, has partnered with Mylan, another leading global pharmaceutical firm. These two companies are actively collaborating and have made significant progress, including obtaining regulatory approval for biosimilars in both the US and Europe. In 2018, Biocon reported a USD 120 million increase in revenue, with a 36 percent growth in its biosimilars segment. That same year, Biocon and Mylan jointly developed a biosimilar drug called Fulphila (trastuzumab), which received approval from the U.S. Food and Drug Administration (FDA). Fulphila has been shown to reduce febrile neutropenia in cancer patients undergoing chemotherapy. It is notably the first biosimilar developed by an Indian pharmaceutical company to receive FDA approval. The drug is currently under review in both Australia and the European Union, and several other biosimilars are also in the pipeline, undergoing regulatory processes to enter the global market.

A list of biosimilar drugs approved in India 2025 includes bevacizumab (Jobevne), denosumab, trastuzumab, filgrastim, epoetin alfa, insulin glargine, and more. Biosimilar companies expected to grow in India by 2025 include Biocon, Dr. Reddy’s, Intas, Zydus, Reliance Life Sciences, Cipla, Lupin, Wockhardt and Enzene. The biosimilar market is regulated in India by CDSCO/DCGI under “Guidelines on Similar Biologics” (2012, revised 2016, 2025 drafts), aligned with global standards.