Organon and Shanghai Henlius Biotech, Inc. announced on October 30, 2024, that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX14. HLX14 is a biosimilar candidate to PROLIA and XGEVA (denosumab).
The FDA's acceptance of the BLA marks a significant regulatory milestone for the biosimilar candidate. This development moves HLX14 closer to potential market entry, which would expand Organon's biosimilars portfolio.
Denosumab is used for various indications, including osteoporosis and the prevention of skeletal-related events in certain cancer patients. The collaboration with Henlius grants Organon exclusive commercialization rights for HLX14 globally, excluding China.
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