Organon (OGN) and Shanghai Henlius Biotech said Wednesday that the US Food and Drug Administration has accepted the biologic license application for HLX14, an investigational biosimilar of denosumab.
Denosumab is approved in several countries for different indications including the treatment of osteoporosis in postmenopausal women, the companies said.
Organon secured the exclusive commercialization rights to HLX14 from Henlius under a 2022 deal.
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