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 | Image: Bio-Thera | Press Release
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