Pharmaceutical company Lupin is intensifying its focus on biosimilars, planning to expand its portfolio and presence in key global markets, as stated by Executive Director and Global CFO Ramesh Swaminathan in an interview with Business Standard.
The company, which has recently become active in the biosimilar sector, received its first approval from the U.S. Food and Drug Administration (USFDA) in December 2025 for the market launch of its anti-cancer biosimilar drug, pegfilgrastim.
According to Swaminathan, pegfilgrastim will enter the US market, while the ophthalmic drug ranibizumab is preparing for launch in the US, Europe, and Japan. The company forecasts that revenue from biosimilars will reach nearly $500 million over the next five years.
Furthermore, Lupin intends to introduce anti-cancer biosimilars Nivolumab, Dinuzumab, and Pertuzumab into the Indian market. The firm is currently implementing products such as the biosimilar for autoimmune disease treatment Etanercept in Europe and Japan through partnerships.
To support this expansion, the company has invested approximately 500 crore rupees in biosimilar manufacturing facilities and plans to increase total investments to around 700 crore rupees. Swaminathan noted that there are currently about 11,000 liters of mammalian and 100 liters of microbial capacity undergoing expansion.
The company does not use a fixed commercialization model for its portfolio but plans to employ a combination of partnerships, third-party distribution, and its own sales force depending on the product and market.
Previously, Lupin collaborated with the American pharmaceutical company Viatris to promote Etanercept in global markets; this mandate subsequently transferred to Biocon Biologics after Biocon Biologics acquired Viatris's global biosimilar.
Lupin is also entering into partnership agreements with global pharmaceutical firms such as Sandoz and Biogaran for distribution in the European Union (EU) market.
This focus on biosimilars aligns with the company's goal of creating additional growth streams around its existing generics manufacturing business. Swaminathan expects the business in India to grow at 25–30 percent above the market level in the 2026–27 fiscal year.
In the US, Lupin faces some short-term competition due to products like the generic Mirabegron for bladder diseases, which was subject to a patent dispute with innovator company Astellas Pharma. The company later reached a $90 million settlement agreement with Astellas, allowing it to continue selling this product in the US.
Swaminathan suggested that there might be some revenue decline in America this year, but new launches next year, such as Apixaban, are expected to support growth. The company sees a potential Compound Annual Growth Rate (CAGR) of about 10 percent in the US over the next five years.
Although Lupin has a presence in South Africa, it is exploring partnership opportunities in various therapeutic areas in the African market. Swaminathan emphasized that the company is already a major player in tuberculosis and rabies vaccines (ARV), which are significant markets for Africa.
Separately, Lupin has initiated the process of attracting external funding for Kaveri Therapeutics, its oncology-focused subsidiary, which contains two specialized oncology programs. This step aims to bring in external capital for developing higher-risk drugs, allowing Lupin to preserve resources for its core pharmaceutical business.
Swaminathan stated that they believe in the potential of these molecules but simultaneously acknowledge the associated risks. He added that Lupin will participate in the financing and intends to remain a majority shareholder in Kaveri, although the final stake will depend on the amount raised and the company's valuation.
The financing process has already begun, and one partner is ready to attract additional investors. However, the company does not yet have a timeline for a Series A round. Swaminathan considers it premature to discuss the potential future listing of Kaveri, noting that this might be considered if the company eventually evolves into a multi-billion dollar business with several successful molecules.