Shots:
Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement
Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…
Shots:
Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025
Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity.
YESAFILI is a…
Shots:
Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26
Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
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…

