Dazublys

Opinion

EMA has issued an opinion on this medicine

trastuzumab

Overview

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.

The applicant for this medicinal product is CuraTeQ Biologics s.r.o.

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 is:

Breast cancer

Metastatic breast cancer

Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC):

• as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments.
• in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
• in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
• in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive MBC, not previously treated with trastuzumab.

Early breast cancer

Dazublys is indicated for the treatment of adult patients with HER2-positive early breast cancer. (EBC).

• following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
• following adjuvant chemotherapy with doxorubicin and cyclophosphamide in combination with paclitaxel or docetaxel.
• in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
• in combination with neoadjuvant chemotherapy followed by adjuvant Dazublys therapy for locally advanced (including inflammatory) disease or tumors> 2 cm in diameter (see sections 4.4 and 5.1).

Dazublys should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).

Metastatic gastric cancer

Dazublys in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Dazublys should only be used in patients with metastatic gastric cancer (MGC) whose tumors have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).

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.

CHMP summary of positive opinion for Dazublys

AdoptedReference Number: EMA/CHMP/126052/2025

Product details

• Name of medicine:
  Dazublys
• Active substance:
  trastuzumab
• International non-proprietary name (INN) or common name:
  trastuzumab
• Therapeutic area (MeSH):
  • Breast Neoplasms
  • Stomach Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01FD01
• EMA product number:
  EMEA/H/C/006219
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation applicant:
  CuraTeQ Biologics s.r.o
• Opinion adopted:
  25/04/2025
• Opinion status:
  Positive