Bio-Thera Reports the US FDA’s Approval of Avzivi (Biosimilar, Avastin)
- 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
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