Shanghai Henlius and Organon Got EMA’s Validation for the MAA of HLX14 (Biosimilar, Prolia & Xgeva)
Shots:
- The EMA has validated the Shanghai Henlius and Organon MAA of HLX14, a biosimilar to Prolia and Xgeva (denosumab) in postmenopausal women with osteoporosis
- The MAA submission is based on the P-III trial, comparing safety, efficacy, tolerability, and immunogenicity of HLX14 with Prolia in postmenopausal women with osteoporosis at high risk for fracture
- Under the license and supply agreement of both companies in 2022, Organon received exclusive right to commercialize two biosimilar candidates, including HLX14 in EU, US, and Canada except China
Ref: Henlius | Image: Henlius
Related News:- Henlius and Organon Report the P-III Study Results of HLX14 (Biosimilar, Denosumab)
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