On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to EYLEA® 2 milligram (mg). AVT06 is an aflibercept biosimilar candidate for the treatment of eye disorders such as neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. Thus far, the FDA has approved five aflibercept biosimilars, with Amgen’s PAVBLU™ being the most recent.
Alvotech is currently developing AVT29, a biosimilar candidate for EYLEA® HD 8 mg. Teva holds commercialization rights for AVT29 in the United States.
As we have previously reported, Alvotech and Teva have partnered for the exclusive commercialization of various biosimilar product candidates and recently announced FDA acceptance of the BLA for AVT05, a proposed golimumab biosimilar to SIMPONI® and SIMPONI ARIA®.
Stay tuned to Big Molecule Watch for further regulatory updates on biosimilars.