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Alvotech Says European Medicines Agency Has Accepted Marketing Application for AVT06
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Alvotech Says European Medicines Agency Has Accepted Marketing Application for AVT06
Aug 15, 2024 2:27 AM

05:12 AM EDT, 08/15/2024 (MT Newswires) -- Alvotech ( ALVO ) said Thursday that the European Medicines Agency has accepted a marketing authorization application for AVT06, the company's proposed biosimilar to Eylea.

Eylea is a widely used biologic for the treatment of eye disorders, the company said. The approvals process is expected to be completed in Q3 2025.

Alvotech ( ALVO ) is responsible for the development and commercial supply of AVT06, while UK-headquartered global pharmaceutical company Advanz Pharma is responsible for registration and has exclusive commercialization rights in Europe, except for France and Germany where the rights are semi-exclusive.

This comes after Alvotech ( ALVO ) reported positive topline results in January from a confirmatory clinical study comparing AVT06 with Eylea.

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