Teva said the launch strengthens its biosimilars strategy and expands access to biologic medicines across Europe
ANYRA is India’s first indigenously developed Aflibercept 2 mg biosimilar
Yesafili, available in vial and prefilled syringe presentations (2 mg/0.05 mL), was the first biosimilar to Eylea approved by Health Canada
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
Yesafili, received marketing authorization approval from the European Commission for the European Union
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
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