Indian drugmakers are recalibrating their biosimilars strategy, seizing on a fresh opportunity created by recent US FDA draft guidelines and a booming American biosimilars market. Companies that were sitting on the fence are now thinking about how to get into the biosimilar race; some are even considering acquisitions to get to market faster, industry sources told Moneycontrol.
"We are looking at biosimilars, the space looks attractive now," said a top executive of a leading pharmaceutical company on condition of anonymity.
Biosimilars are biologic medical products that are almost identical copies of an original product , they are complex to develop requiring clinical trials.
What has changed?
The USFDA’s proposed changes eliminate the need for expensive comparative efficacy studies—long considered the costliest component of biosimilar development—relying instead on advanced analytical and pharmacokinetic data.
Global biosimilar programs typically cost between $100 million and $200 million, but the new framework could slash that by 50%, according to Biocon Managing Director and CEO Sidharth Mittal.
“This is a game-changer,” Mittal said in a recent interview to Moneycontrol. “If comparative clinical trials are no longer mandatory, we can halve development costs and accelerate market entry. It’s a huge boost for companies like us targeting the US, the largest biosimilars market.”
The timing couldn’t be better. The US biosimilars market is projected to balloon from about $22.6 billion in 2025 to more than $90 billion by 2034, according to industry estimates. While biosimilars currently account for just 5% of prescriptions in US, they represent over half of drug spending—a gap that underscores the potential for cost savings and growth. US payers and pharmacy benefit managers increasingly prioritizing biosimilars to curb healthcare costs, the demand outlook is robust.
For Indian drugmakers, the regulatory shift offers a rare opportunity to combine their low-cost manufacturing advantage with streamlined approval pathways.
M&A and licensing deals
Companies are responding with aggressive strategies. Lupin expects its biosimilars portfolio to start contributing to US revenues by fiscal 2027, with at least five launches by 2030, including Pegfilgrastim, Ranibizumab, and Eylea. Sun Pharma, which has historically prioritized specialty drugs, is reassessing its stance. “We are studying and possibly waiting for the clear guidance to come before we take a decision,” Chairman Dilip Shanghvi said in the second quarter earnings call. “Because clearly, this would reduce potential investment, but there will also be impact in terms of future.”
Cipla, meanwhile, has already marked its entry with the launch of filgrastim in the US, signaling its intent to scale up in high-potential segments.
Beyond organic growth, acquisitions are emerging as a key lever. Indian firms are scouting for biosimilar assets and partnerships to fast-track entry and minimize infrastructure costs. Ahmedabad-based Intas Pharmaceuticals in December last year acquired Udenyca, a biosimilar version of the drug pegfilgrastim from US drug maker
Coherus by paying around $558 million. Licensing and distribution partnerships for commercialization is also gaining traction like in the case of Cipla (tie-up wTanvex BioPharma for filgrastim), Dr Reddy's (tie-up with Alvotech for denosumab biosimilar) as companies seek to balance capital efficiency with market reach.
Biosimilars have historically been a modest R&D burn for Indian players, but the new regulatory environment could turn that equation positive within a couple of years. Indian companies spend around 6-8 percent of sales on R&D. A part of that R&D would be routed to biosimilars. Industry analysts expect returns to rival those of complex generics, a segment where Indian firms have already demonstrated global leadership. On flip
It’s not just about cost savings; it’s about speed, scale, and seizing the moment, Mittal of Biocon added.
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