Biosimilar approved for breast cancer
The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Herzuma (trastuzumab biosimilar), from Celltrion Healthcare Hungary, intended for the treatment of breast cancer. Herzuma will be available as a 150 mg powder for concentrate for solution for infusion. The active substance of Herzuma is trastuzumab, a monoclonal antibody (ATC code: L01XC03) that binds with high affinity and specificity to HER2 leading to the inhibition of proliferation of tumour cells that overexpress HER2.
Herzuma is a biosimilar medicinal product. It is highly similar to the reference product Herceptin (trastuzumab), which was authorised in the EU on 28 August 2000. Data show that Herzuma has comparable quality, safety and efficacy to Herceptin.
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