Biosimilar approved by EU for treatment of breast cancer and metastatic gastric cancer
The EU has given marketing approval for Ontruzant a biosimilar candidate referencing Herceptin (trastuzumab), from Samsung Bioepis, for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. It follows a positive recommendation by the Committee for Medicinal Products for Human Use in September, which ruled that Ontruzant (trastuzumab) is highly similar to its reference product Herceptin.
Comment:Patents on Herceptin in Europe expired on 28 August 2015 and will expire in US on 16 June 2019.
Ontruzant is marketed in the EU by Biogen and in the rest of the world by Merck Inc.
Learning Zones
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