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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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
