On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s Eylea® (aflibercept). According to Biocon, the study demonstrated switching patients with diabetic macular oedema (DME) from Eylea® to MYL-1701P produced comparable results in terms of efficacy, safety and immunogenicity. The results were presented at the annual meeting of the American Academy of Ophthalmology.
Biocon’s aflibercept biosimilar Yesafili™ was approved in the US in May 2024. There are currently four other FDA-approved aflibercept biosimilars: Amgen’s Pavblu™ (August 2024), Sandoz’s Enzeevu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024)
Regeneron has sued Biocon, Amgen, Samsung Bioepis, Formycon, Celltrion and Sandoz in US BPCIA litigation regarding aflibercept biosimilars. A permanent injunction was granted against Biocon on 11 June 2024. Biocon filed a Notice of Appeal on 21 June 2024.
Biocon’s Yesafili® is currently the only aflibercept biosimilar approved in the EU (September 2023, with UK approval following in November 2023). Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023 and Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by EMA in August 2024. In July 2024, Altos Biologics announced that it submitted an MAA to the EMA for its aflibercept biosimilar ALT-L9, with marketing approval expected in 2025. At its September 2024 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s Afqlir™ and Samsung Bioepis/Biogen’s Opuviz™.