Dazublys

RSS
Authorised

This medicine is authorised for use in the European Union

trastuzumab
Medicine Human Authorised
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

Dazublys is used to treat adults with certain types of breast or gastric cancers. Dazublys can only be used when the cancer is HER2-positive. HER2-positive means that cancer cells have large quantities of the HER2 protein on their surface, which makes the tumour cells grow more quickly.

Early breast cancer

In patients with early breast cancer (when the cancer has spread within the breast or to the glands under the arm, but not to other parts of the body), Dazublys is used:

  • on its own after surgery, chemotherapy and radiotherapy (treatment with radiation), if applicable;
  • in combination with chemotherapy (docetaxel and carboplatin) after surgery;
  • in combination with chemotherapy (paclitaxel or docetaxel), following a course of chemotherapy with doxorubicin and cyclophosphamide given after surgery;
  • when the cancer is locally advanced (has spread nearby), including when it is inflammatory, or when the cancer is larger than 2 cm. In these cases, it is used in combination with chemotherapy before surgery and then on its own after surgery.

Metastatic breast cancer

In patients with metastatic breast cancer (cancer that has spread to other parts of the body), Dazublys is used:

  • on its own in patients who have had two courses of chemotherapy for metastatic breast cancer, including an anthracycline and a taxane, unless patients cannot take these medicines;
  • on its own when cancer cells have receptors (target) for certain hormones on their surface (HR-positive) and patients have previously received at least one endocrine therapy (treatment which blocks the effect of oestrogens, a female sex hormone), unless they cannot receive this type of treatment;
  • in combination with other chemotherapy (docetaxel or paclitaxel) in patients who have not been previously treated for metastatic breast cancer;
  • in combination with an aromatase inhibitor (endocrine therapy) in patients who have been through menopause and whose tumour is HR-positive, when they have not previously had trastuzumab.

Metastatic gastric cancer

In patients with adenocarcinoma (a type of cancer) of the stomach or gastro-oesophageal junction (cancer at the junction between the stomach and the oesophagus) who have not previously been treated for metastatic disease, Dazublys is used in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil chemotherapy).

Dazublys contains the active substance trastuzumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Dazublys is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Dazublys is Herceptin. 

Dazublys can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of anticancer medicines.

Dazublys is given by infusion (drip) into a vein over 90 minutes, every week or every three weeks depending on the condition being treated. For early breast cancer, treatment is given for a year or until the disease comes back. For metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.

The patient should be monitored for signs of allergic reaction during and after each infusion. Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.

For more information about using Dazublys, see the package leaflet or contact your doctor or pharmacist.

The active substance in Dazublys, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to HER2. About a quarter of breast cancers and a fifth of gastric cancers have large quantities of HER2 on the surface of cancer cells. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. It also stops HER2 from sending signals that cause cancer cells to grow.

Laboratory studies comparing Dazublys with Herceptin have shown that the active substance in Dazublys is highly similar to that in Herceptin in terms of structure, purity and biological activity. Studies have also shown that giving Dazublys produces similar levels of the active substance in the body to those seen with Herceptin.

In addition, a main study involving 690 patients with HER2-positive metastatic breast cancer showed that Dazublys was as effective as Herceptin in treating the condition. In this study, 67% of patients given Dazublys had a complete response (no sign of cancer after treatment) or partial response (shrinkage of the tumour), compared with 69% of those given Herceptin.

Because Dazublys is a biosimilar medicine, the studies on the effectiveness of trastuzumab carried out with Herceptin do not all need to be repeated for Dazublys.

The safety of Dazublys has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Herceptin.

For the complete list of side effects and restrictions of Dazublys, see the package leaflet.

The most common side effects with Dazublys (which may affect more than 1 in 10 people) include heart problems, infections, lung and blood problems, and reactions at the site of infusion.

Dazublys must not be used in patients who have severe dyspnoea (difficulty breathing) when they are at rest because of advanced cancer, or in patients who need oxygen therapy.

Dazublys can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). It should be used with caution in patients who have heart problems or high blood pressure. All patients should have their heart monitored during and after treatment with Dazublys.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Dazublys has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way. In addition, a study in patients with metastatic breast cancer has shown that Dazublys and Herceptin are equivalent in terms of safety and effectiveness in this indication.

All these data were considered sufficient to conclude that Dazublys will have the same effects as Herceptin in its authorised uses. Therefore, the Agency’s view was that, as for Herceptin, the benefits of Dazublys outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dazublys have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Dazublys are continuously monitored. Suspected side effects reported with Dazublys are carefully evaluated and any necessary action taken to protect patients.

Dazublys received a marketing authorisation valid throughout the EU on 30 June 2025.

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Product information

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30/06/2025
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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).

Authorisation details

EMA product number
EMEA/H/C/006219

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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 holder
CuraTeQ Biologics s.r.o

Trtinova 260/1
Cakovice
196 00 Prague-Cakovice
Czechia

Opinion adopted
25/04/2025
Marketing authorisation issued
30/06/2025

Assessment history

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