EirGenix’s biosimilar trastuzumab Received Market Authorization From the European Commission (EC)
Shots:
- Trastuzumab received Market authorization in the EU for the treatment of HER2-positive breast cancer & metastatic gastric cancers. These are the same indications that the EC has authorized for the reference biologic Herceptin
- The market authorization following the EU’s CHMP positive opinion was based on the P-III study that evaluated EG12014 vs trastuzumab in patients with HER2-positive, early-stage breast cancer patients (n=807)
- Sandoz is responsible for the commercialization of drug worldwide (excl. Taiwan, China, Russia, and some Asian countries) whereas EirGenix takes over the development & manufacturing of trastuzumab
Ref: PR Newswire | Image: Sandoz
Related News:- Sandoz Receives the EMA’s CHMP Positive Opinion of Biosimilar Trastuzumab for Breast and Gastric Cancer
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
