Biocon Eyes Acceleration Phase As USFDA Draft Guidelines Open Door To Cheaper Biosimilars: Kiran Mazumdar-Shaw

Biocon is stepping into a decisive new phase in its evolution as a global biosimilars powerhouse, propelled by regulatory shifts in the US, fresh strategic partnerships, and a strengthened insulin and GLP-1 pipeline, executive chairperson Kiran Mazumdar-Shaw told The Economic Times.

She said the company is now uniquely positioned to accelerate growth, lighten its financial load, and scale deeper into the high-value biologics market.

“We are in a sweet spot and a very unique position,” Mazumdar-Shaw said in her conversation with ET. She pointed out that Biocon is the only player with interchangeable insulins at a time when traditional insulin manufacturers are shifting their focus toward GLP-1s. “We are taking that advantage globally,” she said.

Biocon currently stands as the sole company offering interchangeable biosimilar insulin analogues — insulin glargine (Semglee) and insulin aspart (Kirsty) — in the US. Mazumdar-Shaw noted that the acquisition of Viatris' global biosimilars portfolio, often criticised for its debt impact, has actually cemented Biocon's position among the world’s top five biosimilar companies. The business was acquired in 2022 for $3.3 billion, and Biocon Biologics has been working to pare down $1.2 billion in acquisition-related debt.

“People focus too much on the acquisition debt and not enough on the fact that we have become a leading global biosimilars company,” she told The Economic Times. Speaking about the company’s ambitions in GLP-1 analogues, she added: “We have done this successfully for insulins and for liraglutide and are confident that semaglutide will be quite straightforward for us.”

Mazumdar-Shaw said Biocon is poised to benefit significantly from the USFDA’s new draft guidelines, which propose removing the requirement for phase-III clinical trials for certain biosimilars backed by strong chemistry, manufacturing and controls (CMC) data.

According to ET, these draft guidelines eliminate the need for most comparative efficacy trials: the most expensive and slowest phase of biosimilar development. Developers will instead be able to rely on advanced analytical and functional testing to demonstrate similarity. The USFDA also intends to ease pathways for biosimilars to be classified as interchangeable, allowing pharmacists and patients quicker access to lower-cost alternatives.

“Once we get the first approval without phase-III trials, it will set the stage for more launches and significantly reduce our R&D costs,” Mazumdar-Shaw said. She added that this shift will allow Biocon to “do a lot more for the same amount of R&D spend,” giving the company a clear edge over competitors.

Over the past 12–18 months, Biocon has rolled out several biosimilars across key therapy areas, including ustekinumab (Yesintek), aflibercept (Yesafili), insulin aspart (Kirsty), bevacizumab (Jobevne) and most recently denosumab (Bosaya and Aukelso). ET reported that the company has also settled with Amgen on denosumab, paving the way for its upcoming US launch.

With this momentum, Mazumdar-Shaw said Biocon has now entered the “acceleration” stage, building a broad and diversified biosimilar portfolio that few companies — whether Sandoz, Amgen, Pfizer, Celltrion or Samsung — can match in scale and integration. “We have a large basket of biosimilars now in the market and nobody else has this scale of products,” she said. Biocon’s cancer therapies Fulphila (pegfilgrastim) and Ogivri (trastuzumab) already hold over 25% market share in the US.

Speaking to ET, Mazumdar-Shaw said the company’s growth trajectory over the next five years will be “very exciting,” with even larger opportunities emerging beyond 2030 as big-ticket biologics—including next-generation cancer drugs like PD-1 inhibitors—go off patent. Insulin and GLP-1 therapies, she added, are shaping up to be strong adjacencies for Biocon.

She highlighted that Biocon’s longstanding expertise in insulin manufacturing, along with patient familiarity with its devices, gives the company a natural advantage in GLP-1 analogues. Introducing GLP-1s, she said, becomes “seamless” for both the company and patients.