Teva and Alvotech advance biosimilar portfolio in USA

19 February 2025

Icelandic biosimilar company Alvotech (Nasdaq: ALVO) and Israeli drugmaker Teva Pharmaceuticals (TASE: TEVA) have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea (aflibercept).

Originally developed by Regeneron (Nasdaq: REGN) and Bayer (BAYN: DE), Eylea, a widely-used biologic for the treatment of eye disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema and diabetic retinopathy.

In addition to AVT06, which is a biosimilar candidate for Eylea (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a copy of Eylea HD (aflibercept) 8 mg. Teva also holds commercialization rights for AVT29 in the USA.

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