CHMP positive for Herwenda, a biosimilar, intended for the treatment of HER2-positive 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 Herwenda, intended for the treatment of HER2-positive breast and gastric cancer.
The applicant for this medicinal product is Sandoz GmbH. Herwenda will be available as a 150 mg powder for concentrate for solution for infusion. The active substance of Herwenda is trastuzumab, a HER2 inhibitor (ATC code: L01FD01) that binds with high affinity and specificity to HER2, inhibiting proliferation of tumour cells that overexpress HER2.
Herwenda 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 Herwenda has comparable quality, safety and efficacy to Herceptin.
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