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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
