CHMP recommends Tuznue (trastuzumab biosimilar) intended for the treatment of breast and gastric cancer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tuznue,(trastuzumab biosimilar) intended for the treatment of breast and gastric cancer
The applicant for this medicinal product is Prestige Biopharma Belgium BVBA.
Tuznue will be available as a 150 mg and 420 mg powder for concentrate for solution for infusion. The active substance of Tuznue is trastuzumab, a monoclonal antibody (ATC code: L01FD01) that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2.Tuznue 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 Tuznue has comparable quality, safety and efficacy to Herceptin (trastuzumab).
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