United Laboratories' Biosimilar Semaglutide Accepted for Review by China's NMPA

United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA

Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing for a biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step towards introducing a more accessible version of the popular GLP-1 agonist in the Chinese market.

Semaglutide’s Regulatory History in China
Semaglutide, a GLP-1 receptor agonist, has already been approved in China for the treatment of type 2 diabetes in 2021 and for weight loss in 2024. Despite its growing popularity and clinical benefits, no biosimilar version of semaglutide has yet been approved in the country. United Laboratories’ submission is the latest effort to bring a more cost-effective alternative to patients in need.

Competitive Landscape
While United Laboratories’ biosimilar version of semaglutide is under review, other domestic players have also filed for marketing approval. Competitors such as Jiuyuan Gene, Livzon Pharma, and Qilu Pharma have submitted their own versions of the drug, indicating a growing interest in tapping into the potential market for GLP-1 agonists in China. This competitive environment underscores the significant demand for affordable alternatives to branded therapies like Ozempic and Wegovy.

Implications for the Chinese Market
The acceptance of United Laboratories’ market filing by the NMPA highlights the ongoing efforts to expand treatment options for patients with type 2 diabetes and obesity. Biosimilar versions of semaglutide could offer enhanced accessibility and affordability, potentially driving broader adoption of GLP-1 receptor agonists in China. As regulatory reviews progress, the market will be closely watching for any developments that could shape the future of diabetes and weight management therapies in the region.-Fineline Info & Tech

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Insight, China's Pharmaceutical Industry