On 18 February 2026, Sandoz announced that the FDA has approved an indication extension for Enzeevu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, to include macular oedema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema. Enzeevu® was approved by the FDA for nAMD in August 2024.
Enzeevu® has not yet launched in the US. Under a settlement entered into with Regeneron, announced in September 2025, Sandoz is permitted to launch Enzeevu® in the US in Q4 2026, or earlier in certain undisclosed circumstances.
The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 (BLA accepted for review February 2025, due to launch Q4/2026, subject to regulatory approval).