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eEUView - PUBLIC HEALTH
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Brussels, 30 March 2023
The CHMP* recommended the granting of a marketing authorization for a biosimilar medicine called Ontruzant (trastuzumab), developed by Samsung Bioepis Netherlands B.V.
Ontruzant is used for the treatment of breast cancer, and it works by targeting the human epidermal growth factor receptor 2 (HER2), which is overexpressed in some types of breast cancer.
Biosimilar medicines are highly similar versions of existing biological medicines, and they are designed to have the same effectiveness and safety profile as the original medicine.
Ontruzant is intended to be used in the same way as the reference medicine, Herceptin, which has been on the market since 2000. The approval of Ontruzant is expected to increase competition in the market for HER2-targeted therapies and improve access to treatment for patients with breast cancer.
* The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
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Source: EMA - © EMA [1995-2023]
Source: EMA - © EMA [1995-2023]
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