Biocon Arm Gets US FDA Nod for Yesafilli, Enters US Opthalmology Market

Biocon Biologics Limited, a wholly owned subsidiary of Biocon Limited announced that the US Food and Drug Administration has approved the Company’s first-to-file application for Yesafili, an interchangeable biosimilar aflibercept.

Key Takeaways from Biocon Biologics:

• Biocon Biologics receives US FDA approval for Yesafili.
• Biocon Biologics’ expansion into the ophthalmology therapeutic area in the US and UK.
• Data shows YESAFILI has comparable quality, safety, and efficacy to Eylea.

The approval marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the US following a steady track record of approval in Europe and the UK where it was the first biosimilar aflibercept to be approved. 

YESAFILI is a vascular endothelial growth factor inhibitor used to treat different ophthalmology conditions. According to data, YESAFILI has comparable quality, safety, and efficacy to Eylea. 

YESAFILI is used in the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularization. 

About Biocon Biologics Limited:

Biocon Biologics Limited is a leading global company that offers a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. It has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the US and six in Canada, Biocon Biologics has a robust pipeline of 20 biosimilar assets across multiple therapy areas.

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