Dazublys (trastuzumab), applicant: CuraTeQ Biologics s.r.o

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dazublys, intended for the treatment of breast and gastric cancer.

Dazublys will be available as a 150 mg powder for concentrate for solution for infusion. The active substance of Dazublys 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.

Dazublys 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 Dazublys has comparable quality, safety and efficacy to Herceptin (trastuzumab).

More information on biosimilar medicines can be found here.

The full indication for Dazublys is described in the Summary of Opinion.

Dazublys should be prescribed by physicians experienced in the administration of cytotoxic chemotherapy and should be administered by a healthcare professional only.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.