08:17 AM EDT, 05/24/2024 (MT Newswires) -- Organon (OGN) and Shanghai Henlius Biotech said Friday their marketing authorization applications for HLX14, a denosumab biosimilar, have been validated by the European Medicines Agency.

The submissions were based on a phase 3 study comparing HLX14 with denosumab in postmenopausal women with osteoporosis, the companies said.

Henlius licensed HLX14 to Organon in 2022 for exclusive commercialization in several markets.