US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)
Organon & Co. (OGN)
Company Research
Source: Business Wire
SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab).This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241029648679/en/Denosumab has been approved in various countries and regions under different trade names for a range of different indications, such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others.In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.The filing is based on data from a
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