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Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area

ALVO
  • The European Commission approved Alvotech's AVT03 as a biosimilar to Prolia & Xgeva (denosumab) on November 24, 2025.
  • AVT03 is approved in two presentations: a 60 mg/mL pre-filled syringe for osteoporosis treatment & a 70 mg/mL vial for preventing skeletal events in cancer patients.
  • The European denosumab market is valued at approximately US$1.2 billion based on originator sales in the last 12 months including Q2 2025.
  • Approval was based on comparative analytical, pharmacokinetic, pharmacodynamic data & a confirmatory clinical study showing equivalent efficacy & safety to the reference product.
  • Commercialization in the EEA, Switzerland, & the UK will occur via partnerships with STADA & Dr. Reddy's, who hold semi-exclusive rights.
  • STADA will market AVT03 as Kefdensis (Prolia biosimilar) & Zvogra (Xgeva biosimilar).
  • Dr. Reddy's will market AVT03 as Acvybra (Prolia biosimilar) & Xbonzy (Xgeva biosimilar).
  • AVT03 targets the RANK ligand protein to reduce osteoclast function, bone resorption, & cancer-induced bone destruction.
  • Alvotech currently has nine biosimilar candidates in its pipeline for autoimmune, eye, osteoporosis, respiratory, & cancer treatments.
  • AVT03 is also approved for marketing in Japan in addition to the EEA.