On 16 September 2025, STADA announced that Afiveg®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) received European Commission approval as 40mg/ml solution for injection in pre-filled syringes and vials. The approval follows a positive opinion from the EMA’s CHMP in June 2025.
According to STADA, launch of Afiveg® in Europe is scheduled to begin in Germany following “expected loss of EU protection for the Eylea® reference product in Q4 2025”.
The approval of Afiveg® means that STADA now has two ophthalmology biosimilars approved in Europe, with Ximluci®, biosimilar to Genentech’s Lucentis® (ranibizumab), EU approved in November 2022 and launched in Europe in April 2023.
Other aflibercept biosimilars approved in Europe include: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), and Alvotech/Advanz’s Mynzepli® (August 2025).