Bio-Thera Reports the US FDA’s Approval of Avzivi (Biosimilar, Avastin)
Shots:
- The FDA granted approval to Avzivi (BAT1706) based on a thorough analysis of analytical, non-clinical, & clinical data and the comparative studies b/w Avzivi and Avastin which confirmed biosimilarity by assessing structural, physicochemical, and biological properties
- The randomized, double-blind, three-arm parallel P-III trial investigated Avzivi vs Avastin for their efficacy, safety, and immunogenicity in treating advanced non-squamous NSCLC
- Bio-Thera will develop and manufacture Avzivi, while Sandoz has global (incl. US) commercialization rights as per a license and commercialization agreement initiated in Sep 2021
Ref: Bio-Thera Solutions | Image: Bio-Thera Solutions
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
