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Biocon's arm inks pact to commercialize biosimilar Aflibercept Worldwide

13-Dec-25 15:17 Hrs IST

This follows an earlier settlement that addressed the U.S. and Canadian markets.

The agreement clears the way for Biocon Biologics to commercialize Yesafili globally. Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used to treat multiple ophthalmology conditions, including neovascular (wet AMD) age-related macular degeneration, 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).

As part of the agreement, all pending litigation among Biocon Biologics, Regeneron, and Bayer has been dismissed. Biocon Biologics plans to launch Yesafili in the United Kingdom in January 2026, followed by launches in other settled countries in March 2026, or earlier in certain circumstances. The other terms of the settlement remain confidential.

The European Commission (EC) and the Medicines & Healthcare products Regulatory Agency (MHRA) have previously approved YESAFILI.

Yesafili has already received approval from the European Commission (EC) and the UK Medicines & Healthcare products Regulatory Agency (MHRA). Biocon Biologics had earlier secured market entry for the U.S. in April 2025, targeting the second half of calendar year 2026, and launched the product in Canada earlier this year, with market entry secured in March 2024.

Shreehas Tambe, CEO & managing director, Biocon Biologics, said, 'This settlement paves the way for Biocon Biologics to make available our biosimilar Aflibercept globally. This milestone expands our presence in the ophthalmology therapeutic area as we work closely with healthcare systems to increase access to patients everywhere.'

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.

On a consolidated basis, Biocon reported net profit of Rs 84.50 crore in Q2 September 2025 as against net loss of Rs 16 crore in Q2 September 2024. Net sales rose 20.24% YoY to Rs 4262.50 crore in Q2 September 2025.

The counter added 1.34% to currently trade at Rs 386.65 on the BSE.

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