China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes.
Drug Profile
Insulin degludec, a long-acting insulin analogue with a unique mechanism of action, is approved in multiple markets, including the US, Europe, Japan, and China. Huadong’s biosimilar has demonstrated comparability with the originator in terms of clinical efficacy and safety in Phase III clinical trials.-Fineline Info & Tech
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