Drug Approval | June 27, 2025
Biocon Biologics receives Health Canada approval for Yesafili
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries
Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
This agreement paves the way for the introduction of YESAFILI into the Canadian market
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
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