Overview

Zercepac is a cancer medicine used to treat the following conditions:

  • early breast cancer (when the cancer has spread within the breast or to the lymph nodes [‘glands’] under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Zercepac is used before surgery in combination with chemotherapy and then again after surgery on its own;
  • metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own when other treatments have not worked or are not suitable. It is also used in combination with other cancer medicines: paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).

Zercepac can only be used when the cancer overexpresses HER2: this means that the cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.

Zercepac is a ‘biosimilar medicine’. This means that Zercepac is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zercepac is Herceptin.

Zercepac contains the active substance trastuzumab.

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

It is given by infusion (drip) into a vein over 90 minutes either once a week or once every 3 weeks for breast cancer, and once every 3 weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective. The dose depends on the patient’s body weight, on the condition being treated and on whether Zercepac is given every week or every 3 weeks.

The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion for signs such as fever and chills. Patients who do not have significant reactions to the first 90?minute infusion can receive subsequent infusions over 30 minutes.

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

The active substance in Zercepac, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 from producing signals that cause the tumour cells to grow.

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

In addition, one study involving 649 patients with previously untreated metastatic breast cancer that overexpressed HER2 showed that Zercepac was as effective as Herceptin in treating the condition. Patients received Zercepac or the reference medicine Herceptin, together with another cancer medicine, docetaxel. A response to treatment after 24 weeks was seen in around 71% of the patients treated with either medicine (231 of 324 given Zercepac, and 232 of 325 given Herceptin).

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

The safety of Zercepac 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. The most common or serious side effects with Zercepac are heart problems, reactions related to the infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.

Zercepac can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.

Zercepac must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. It must not be used in patients whose advanced cancer causes serious breathing problems even when resting, or who need oxygen therapy.

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

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zercepac has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way. In addition, studies in metastatic breast cancer that overexpressed HER2 have shown that the effectiveness of Zercepac infusion is equivalent to that of Herceptin infusion.

All these data were considered sufficient to conclude that Zercepac will behave in the same way as Herceptin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Herceptin, the benefits of Zercepac 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 Zercepac have been included in the summary of product characteristics and the package leaflet.

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

Zercepac received a marketing authorisation valid throughout the EU on 27 July 2020.

Zercepac : EPAR - Medicine overview

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Zercepac : EPAR - Risk-management-plan summary

Product information

Zercepac : EPAR - Product information

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Latest procedure affecting product information: IA/0029

10/07/2023

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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).

Zercepac : EPAR - All authorised presentations

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Product details

Name of medicine
Zercepac
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

Zercepac 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

Zercepac 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).
  • 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 Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer

Zercepac 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-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Zercepac should only be used in patients with metastatic gastric cancer (MGC) whose tumours 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.

Authorisation details

EMA product number
EMEA/H/C/005209

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
Accord Healthcare S.L.U.

Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Opinion adopted
28/05/2020
Marketing authorisation issued
27/07/2020
Revision
9

Assessment history

Zercepac : EPAR - Procedural steps taken and scientific information after authorisation

Zercepac : EPAR - Public assessment report

CHMP summary of positive opinion for Zercepac

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