India's Biocon developing its own version of Wegovy, clinical trial likely next year

By Rishika Sadam

HYDERABAD (Reuters) - Indian drugmaker Biocon, looking to grab a piece of the exploding weight-loss drug market as early as possible, is developing its own version of Novo Nordisk's wildly popular Wegovy and is prepared to conduct a clinical trial next year if needed, the CEO told Reuters.

Wall Street has forecast the market for this new generation of obesity treatments reaching at least $100 billion by the end of the decade, and Biocon is taking steps to be a part of that windfall.

"We're going to develop semaglutide for India even if it requires a clinical trial," Chief Executive Officer Siddharth Mittal said in an interview of the active ingredient in Wegovy and Ozempic. "We're striving to be in the market as one of the early players. Either it would be in 2026 or not too late after that."

The Bengaluru-based company, which derives most of its revenue from foreign markets such as the United States, also aims to first launch generic versions of the weight-loss drugs in other emerging markets such as Brazil, Mexico, and Saudi Arabia.

Semaglutide will lose patent protection in those countries in 2026, Mittal said, adding that the company is talking to local manufacturers regarding partnerships to ensure supply.

Novo did not immediately respond to a request for comment on patent expirations in the respective countries.

Biocon will first try to get a waiver on clinical trials from Indian regulators and instead submit bioequivalence studies showing that their version has an equivalent effect as semaglutide, Mittal said.

The company is also developing a version of tirzepatide, the active ingredient in Eli Lilly's rival obesity treatment Mounjaro and Zepbound, Mittal said, without providing details on the timing or initial marketing strategy.

Both Novo and Lilly have so far been unable to keep up with seemingly insatiable demand for their obesity treatments.

Biocon has been spending roughly 2.5 billion rupees ($30 million) a year on generics research and development with 40% dedicated to developing peptides including for the weight-loss drugs. Biocon will likely face competition from Indian rivals such as Dr Reddy's and Cipla, which are aiming to bring their own versions of Wegovy to India, subject to patent expiries.

Novo has so far launched Wegovy in a few wealthy countries, but said it aims to bring the drug to India by 2026.

Lilly diabetes treatment Mounjaro is under review by India's drug regulators for weight loss. It was approved for weight loss in Europe under the same brand name but is sold in the United States for obesity as Zepbound.

Wegovy helped patients in clinical trials lose an average of 15% of their body weight, while Mounjaro led to an average loss of 18%. The medicines belong to a class of therapies known as GLP-1 receptor agonists which help control blood sugar and slow digestion, helping people feel full longer.

Biocon has received UK approval for its version of Novo's Saxenda, an earlier generation GLP-1 diabetes drug that also helped people lose about 5% of their body weight. It has also submitted the therapy for approval in Europe and India, Mittal said.

($1 = 83.5310 Indian rupees)

(Reporting by Rishika Sadam; Editing by Bill Berkrot)

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