CHMP recommends Ontruzant (trastuzumab biosimilar) to treat breast cancer and gastric cancer. Samsung Bioepis + Merck Inc.
Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Ontruzant a biosimilar candidate referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide on the grant of a marketing authorization for Ontruzant If a marketing authorization is granted by the EC, Ontruzant will be commercialized in the European Union by Merck Inc.
Comment: Ontruzant is the first biosimilar candidate referencing Herceptin (trastuzumab) to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
A US FDA filing for SB 3 is also expected be
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