European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®

REYKJAVIK, Iceland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- 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 Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s 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 Alvotech’s commercial partners, STADA Arzneimittel AG (“STADA”) and Dr. Reddy’s Laboratories SA (“Dr. Reddy’s”), each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.

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