Alvotech (ALVO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human use adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva. Pending approval, the biosimilar will be marketed by Alvotech’s commercial partners, STADA Arzneimittel and Dr. Reddy’s Laboratories (RDY), each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK. AVT03 remains under EMA regulatory review with a final decision by the European Commission pending.
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