Sandoz Receives the EMA’s CHMP Positive Opinion of Biosimilar Trastuzumab for Breast and Gastric Cancer
Shots:
- The EMA’s CHMP granted a positive opinion recommending marketing authorization of the biosimilar trastuzumab (150mg, IV) to treat HER2+ metastatic breast & gastric cancer. Trastuzumab was developed by EirGenix and is licensed by Sandoz
- The opinion was based on the comprehensive analytical, preclinical, and clinical results incl. evidence derived from an extensive analytical characterization along with results from a P-I PK/PD study and a confirmatory P-III study in breast cancer patients
- Both studies met their 1EPs & showed that the biosimilar was non-inferior to the reference biologic in terms of PK, efficacy, safety, and immunogenicity
Ref: Novartis | Image: Sandoz
Related News:- Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02
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