The race to win approval in a major market for a biosimilar referencing Herceptin (trastuzumab), the world’s joint second-biggest selling cancer drug, has been all but won.
With the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending Samsung Bioepis’ Herceptin copycat, branded as Ontruzant, approval is highly likely within two months.
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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