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
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
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