When launching a drug as big as semaglutide, even as a generic, the market expectations are immense, and any fumble on the part of the drugmaker can take a toll.
Case in point, Dr. Reddy’s share price sank Thursday—ultimately landing at a decline of around 3.5% by 8 a.m. ET—on news that the Indian pharma will delay commercial supplies of its generic version of Novo Nordisk’s GLP-1 receptor agonist for obesity and Type 2 diabetes after uncovering unspecified issues related to the product’s active pharmaceutical ingredient.
Commercial supplies of Dr. Reddy’s semaglutide, which has now debuted in India and Canada, “will be delayed for a certain period of time,” the company said in a July 9 filing on India’s BSE stock exchange.
The move comes after some of the firm’s semaglutide batches were “found to be out of specification due to an issue associated with the active pharmaceutical ingredient (API) used in the product,” per the filing. Dr. Reddy’s noted that it’s delaying supplies of the med as it investigates the source of the problem and takes actions to safeguard product quality.
“There is no impact on patient safety or on the product's existing global regulatory filings,” Dr. Reddy’s clarified, adding that it remains focused on offering dependable supplies of its semaglutide product around the world.
Alongside many other local drugmakers like Zydus and Sun Pharma, Dr. Reddy’s joined a wave of generic semaglutide launches in India earlier this year. More recently, Dr. Reddy’s was among the first clutch of companies to launch a generic semaglutide product in Canada, specifically in the drug’s Type 2 diabetes indication.
Novo’s branded semaglutide products carry the Wegovy and Ozempic brand names across their respective obesity and Type 2 diabetes uses.
Dr. Reddy’s did not specify in its filing when it expects the issue with its semaglutide supply to be resolved.
In its home market in India, Dr. Reddy’s has sold roughly 31,000 units of its generic semaglutide across its oral formulation and specific injectable brands for the GLP-1 med’s diabetes and obesity indications since March, Bloomberg said this week, citing data from market research outfit Pharmarack.
When Novo’s semaglutide patents expired in India back in March, nearly all of India’s generics heavyweights had launches on deck, including Dr. Reddy’s, Sun, Cipla, Biocon, Lupin, Natco, Zydus and Mankind.
With so many players vying for a spot in India’s massive and growing market for GLP-1 medications—expected to boom now that generics are launching and bringing substantial price cuts with them—Dr. Reddy’s semaglutide supply stumble could put the company on the backfoot in its own territory.
Supply constraints early in the launches of Novo's semaglutide and Eli Lilly's rival tirzepatide products Zepbound and Mounjaro led to major headaches for both companies.
While the Big Pharmas have managed to sort out manufacturing capacity and restore stability to their metabolic medicine supply chains, protracted shortfalls in the U.S. earlier in the 2020s fueled a lucrative GLP-1 compounding market that has remained difficult to snuff out.