AVT03 Gains EMA Positive Opinion

  Published 6 months ago

Dr. Reddy's AVT03 biosimilar gets EMA CHMP positive opinion, pending European Commission approval for marketing.

  • AVT03 mirrors Prolia and Xgeva, targeting osteoporosis and cancer bone metastasis treatments across European markets.
  • Dr. Reddy's holds semi‑exclusive European rights, while Alvotech co‑develops and distributes the biosimilar in collaboration.
  • UK MHRA approval will follow via the International Recognition Procedure after European authorization is confirmed successfully.

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