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, safety, efficacy & immunogenicity
- Additionally, Biocon Biologics reached a settlement in Mar, 2024 with Bayer & Regeneron, allowing Canadian launch of Yesafili by Jul 1, 2025
Ref: Biocon Biologics | Image: Biocon Biologics & Regeneron
Related News:- The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)
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