Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)
Shots:
- The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer
- The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi vs Avastin among advanced non-squamous NSCLC patients, Results showed similarity b/w the products
- Under the license agreement of 2021, Bio-Thera will develop and manufacture Avzivi, while Sandoz has commercial rights in US, EU, Canada & selected regions
Ref: Bio-Thera Solutions | Image: Bio-Thera Solutions
Related News:- Bio-Thera Reports the US FDA’s Approval of Avzivi (Biosimilar, Avastin)
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