Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology
Shots:
- The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)
- The approval was supported by analytical, nonclinical & clinical data from P-III (INSIGHT) study of Yesafili vs Eylea in diabetic macular edema patients, confirming its similarity in PK, safety, efficacy & immunogenicity
- Under settlement agreement with Bayer, launch of biosimilar in Canada is anticipated on Jul 1, 2025. Additionally, it was approved across the EU in Sep 2023 and across the UK in Nov 2023
Ref: Biocon Biologics | Image: Biocon Biologics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
