China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide), produced by subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, has been accepted by the National Medical Products Administration (NMPA). The drug is intended as an adjunctive therapy for adult patients needing long-term weight management alongside a low-calorie diet and increased physical activity.
Drug Profile
Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used globally to improve glycemic control in type 2 diabetes and treat obesity or overweight patients. The drug was approved in Europe (2009), the US (2010), and China (2011) under the brand name Victoza, and later gained approvals for weight management in the US (2014) and Europe (2015).
Market Filing Details
Zhongmei Huadong is the first domestic firm to file a liraglutide biosimilar with two indications in China. The NMPA’s acceptance marks progress toward offering a more accessible treatment option for weight management in the country.-Fineline Info & Tech
