On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).
Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.
There are four aflibercept biosimilars already approved (but not yet launched) in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025). Celltrion’s Eydenzelt®/CT-P42 (aflibercept) received a positive opinion at the CHMP’s December 2024 meeting, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.
At its January 2025 meeting, the CHMP also provided good news for CuraTeQ, adopting a positive opinion for its Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) for the treatment of neutropenia. This comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.