Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met all generic review requirements, with its quality, safety, and efficacy found to be consistent with U.S. marketing standards, although it is temporarily unavailable due to existing patent rights or a valid exclusivity period.
Liraglutide, a human glucagon-like peptide 1 (GLP-1) analog, is a significant therapeutic target for diabetes treatment and has multiple physiological functions. These include glucose-dependent promotion of insulin secretion, protection of pancreatic islet beta cells, delayed gastric emptying, and decreased appetite. Previously, Hybio Pharma’s liraglutide raw materials had successfully passed the FDA’s technical review.- Flcube.com
