On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all indications approved for EYLEA®. EYDENZELT® is Celltrion’s first biologic product approved in Canada in the ophthalmology space. According to media reports, Celltrion launched EYDENZELT® in mid-December in major European markets, including U.K. and Germany.
Additionally, on November 24, 2025, Sandoz announced the European launch of AFQLIR® (aflibercept). AFQLIR® is a 2 mg vial kit and pre-filled syringe for intravitreal injection for the treatment of various retinal diseases to prevent disease-related blindness. AFQLIR® was approved by the European Commission in November 2024 for the same indications in the treatment of adult patients as the reference product, EYLEA®. According to Sandoz, AFQLIR® will be launched across Europe, beginning in the U.K., followed by Germany, France, and other countries.
Stay tuned to Big Molecule Watch as we continue to monitor updates in the biosimilars industry.