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 | Image: Biocon | Press Release
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