Biocon Biologics Receives EMA’s CHMP Positive Opinion of Yesafili (biosimilar, aflibercept)
Shots:
- The EMA’s CHMP has issued a positive opinion recommending approval of Yesafili, an aflibercept biosimilar. The EC decision on the approval is expected at the end of Sept 2023
- Yesafili is intended for the treatment of neovascular (wet AMD), visual impairment due to macular oedema secondary to RVO, visual impairment due to DME, and myopic CNV. The results showed that Yesafili has comparable quality, safety, and efficacy to Eylea
- Eight biosimilars have been commercialized by Biocon Biologics in emerging & advanced markets incl. the US, EU, Australia, Canada, and Japan. The company also has 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases
Ref: Biocon Biologics | Image: Biocon Biologics
Related Post:- Biocon Biologics and its Partner Viatris Receive the Complete Response Letter from the US FDA for Bevacizumab Biosimilar
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