On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India for multiple ophthalmic indications (in 40mg/ml vial form for injection). Biocon is required to submit a Phase IV (post-marketing) clinical trial protocol to the CDSCO within 3 months of the grant of marketing authorisation.
Biocon also announced on 18 September 2025 that Yesafili® (aflibercept), in vial and prefilled syringe presentations, is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases.
Yesafili® was reported to be the first aflibercept biosimilar approved in Canada in June 2025 and was launched in July 2025 under a March 2024 settlement between Biocon and Regeneron/Bayer.
Biocon’s Yesafili® was approved in Europe in September 2023 but is not yet on the market. In April 2025, Biocon and Regeneron settled US BPCIA litigation regarding aflibercept, paving the way for a US launch of Yesafili® in the second half of 2026, or earlier under certain undisclosed circumstances.