European regulator recommends Alvotech's denosumab biosimilar
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European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
September 22, 2025 6:15 AM EDTREYKJAVIK, ICELAND (September 22, 2024) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotechs proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial). Pending approval, the biosimilar will be marketed by Alvotechs commercial partners, STADA Arzneimittel AG (STADA) and Dr. Reddys Laboratories SA (Dr. Reddys), each... More
