China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has approved its application to withdraw the market filing for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This decision comes as part of a strategic adjustment in response to policy and regulatory changes in the pharmaceutical market.
Understanding Liraglutide and Its Role in Diabetes Treatment
Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a significant drug in the treatment of diabetes. It promotes insulin secretion in a blood glucose-dependent manner, protects pancreatic islet β cells, delays gastric emptying, and decreases appetite, making it an effective therapy for managing blood sugar levels.
Hybio’s Filing History and Strategic Adjustment
Hybio Pharma initially filed its product under Category 2.2 with the NMPA in July 2022. However, due to adjustments in policy and regulation, the company decided to withdraw its application. Moving forward, Hybio Pharma will base its filing strategy on the evolving market situation to ensure alignment with the latest regulatory frameworks.-Fineline Info & Tech
