On 23 August 2024, the US FDA approved Amgen’s Pavblu™ (ABP 938, aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept), for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy.
Pavblu™ is the fifth aflibercept biosimilar to be approved in the US, following Sandoz’s Enzeevu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Samsung Bioepis’ Opuviz™/SB15 (May 2024) and Biocon’s Yesafili™ (May 2024). Opuviz™, Yesafili™ and Ahzantive® are each approved for nAMD, macular oedema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema, while Enzeevu™ is approved for nAMD only.
Regeneron has sued Amgen, Samsung Bioepis, Biocon, Formycon and Celltrion in US BPCIA litigation regarding aflibercept biosimilars.