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Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Shots:

  • The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
  • STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use vial), while Dr. Reddy’s will offer Acvybra (60mg/mL PFS) & Xbonzy (70mg/mL vial)
  • Denosumab is a mAb that works by targeting Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), which regulates bone metabolism & osteoclast formation

Ref: Alvotech | Image: Alvotech| Press Release

Related News:- Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

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