On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME) or myopic choroidal neovascularisation (CNV).
Pavblu®, together with a second Amgen aflibercept biosimilar Skojoy® (for which the marketing application was withdrawn on 4 March 2025), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in January 2025.
Pavblu® is the seventh aflibercept biosimilar approved in Europe following: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025).
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’s launch of the product.
The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017. There are four other bevacizumab biosimilars FDA approved: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), and Bio-Thera/Sandoz’s Avzivi® (December 2023).