Alvotech Eyeing US Aflibercept Biosimilar Approval This Year With FDA Acceptance

Teva Holds US Commercialization Rights; Market Opened By Amgen Last Year

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

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Alvotech welcomed the “advantage of our fully integrated approach and broad in-house capabilities in both R&D and manufacturing,” after the US Food and Drug Administration accepted for review its AVT06 proposed biosimilar to Eylea (aflibercept) 2mg, for which Teva will handle commercialization upon launch.

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