On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.
Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026.
Yesafili™ is only the second aflibercept biosimilar on the US market, following the launch of Amgen’s Pavblu® 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 that biosimilar. The FDA has not designated Pavblu® as interchangeable with Eylea®.
Biocon’s launch of Yesafili™ leads a stream of upcoming aflibercept biosimilar launches in the US resulting from litigation settlements, including Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 due to launch Q4/2026, subject to regulatory approval).
In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili™ in Europe and ROW, permitting Biocon to commercialise Yesafili™ in Europe/ROW from March 2026, other than in the UK (where it launched in January 2026) and Canada (where it launched in July 2025 as a result of a Canadian settlement).