On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept). Alvotech states that it expects that the process to obtain final market authorization could be completed by the third quarter of 2025. According to the announcement, “Alvotech is responsible for development and commercial supply of AVT06,” and “Advanz Pharma is responsible for registration and has exclusive commercialization rights in Europe, except for France and Germany where the rights are semi-exclusive.” According to Joseph McClellan, Chief Scientific Officer of Alvotech, “EMA acceptance takes us a step closer to making AVT06 available in Europe, which is good news for patients and caregivers.”
Alvotech is also developing AVT29, a high dose (8 mg) biosimilar of EYLEA.
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