Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)
Shots:
Shots:
- The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regions
- Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs denosumab
- Additionally, Henlius received a GMP certificate from Belgium’s FAMHP for production lines related to HLX14 & another product, plus in 2022, it licensed Organon exclusive rights to 2 biosimilars, incl. HLX11, for the US, EU, & Canada (excl. China)
Ref: Henlius | Image: Henlius | Press Release
Related News:- HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com