Korean winner in race to gain Herceptin biosimilar nod in major market
Samsung Bioepis has had its marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), approved by the European Commission (EC).
Ontruzant, which will be commercialized by US pharma giant Merck & Co (NYSE: MRK), is the first biosimilar referencing Herceptin to receive regulatory approval not just in Europe, but in either of the world’s major markets.
Herceptin is marketed by Swiss pharma giant Roche’s (ROG: SIX) Genentech unit and is used for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
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