Dr Reddy's Faces Delay in Semaglutide Launch in Canada

Dr. Reddy's Laboratories (DRL) will probably take some time to release its generic injectable semaglutide in Canada after receiving the health regulatory body, Health Canada's Pharmaceutical Drugs Directorate, Notice of Non-Compliance (NoN).

The authority has asked for further clarifications on certain aspects of the company's regulatory submission, according to the analysts.

The share price of DRL dropped by over 4% due to the setback, as the analysts are suggesting that the delay in the expected launch time is between 8 and 12 months. "As this is a major product opportunity for the company in the near term, we anticipate short-term share price volatility," Nuvama Institutional Equities commented.

One of the most sought-after molecules worldwide is semaglutide, the active ingredient in the weight-loss drugs Wegovy and Ozempic, made by Novo Nordisk, with many pharmaceutical companies lining up to introduce generics once the patents expire from 2026. The first market that will witness the end of the semaglutide patent is Canada, starting January 2026, is what people are anticipating.

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According to the analysts, Health Canada is being very cautious because no regulating authority from the developed markets, including the USFDA, has given the nod to a generic version of semaglutide. DRL, which is the first-to-file (FTF) holder for the drug in Canada, is currently in its third review cycle.

DRL is still willing to bet on the success of its endeavor despite the hitch. "We stand behind the quality, safety, and equivalence of the product we are proposing," the company affirmed, adding that it will be quick to respond to the regulator while keeping the FY27 launch targets across the global markets.