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Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)

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  • 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

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