Herzuma

trastuzumab

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Herzuma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Herzuma.

For practical information about using Herzuma, patients should read the package leaflet or contact their doctor or pharmacist.

What is Herzuma and what is it used for?

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

  • 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) 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 tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma 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 in patients in whom previous treatments have failed. It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).

Herzuma can only be used when the cancer has been shown to ‘overexpress HER2’: this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.

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

Herzuma contains the active substance trastuzumab.

How is Herzuma used?

Herzuma 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 available as a powder used to make up a solution for adding to an infusion (drip) into a vein. The infusion is given over 90 minutes every week or every three weeks for breast cancer, and every three 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 recommended dose depends on the patient’s body weight, on the condition being treated and on whether Herzuma is given weekly or three-weekly.

The infusion may be associated with allergic reactions, so the patient should be monitored during and after the infusion. Patients who tolerate the first 90‑minute infusion can receive subsequent infusions over 30 minutes.

For further information, see the package leaflet.

How does Herzuma work?

The active substance in Herzuma, trastuzumab, is a monoclonal antibody (a type of protein) that has been 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 producing signals that cause the tumour cells to grow.

What benefits of Herzuma have been shown in studies?

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

In addition, one main study involving 549 patients with early breast cancer that overexpressed HER2 showed that Herzuma was as effective as Herceptin. Patients were given either Herzuma or Herceptin with other cancer medicines before surgery to remove the cancer, and then the same medicine on its own every three weeks for 1 year. There were no relevant differences in the main measure of effectiveness (absence of invasive cancer cells in the breast or in linked tissues called lymph nodes) between the two products: this was seen in nearly 44% of those given Herzuma (118 of 271) and 47% of those given Herceptin (131 of 278).

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

What are the risks associated with Herzuma?

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

Herzuma 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.

Herzuma 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 who have serious breathing problems because of advanced cancer, even when resting, or who need oxygen therapy.

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

Why is Herzuma approved?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Herzuma has been shown to have a comparable quality, safety and effectiveness to Herceptin.

Therefore, the Agency’s view was that, as for Herceptin, the benefit outweighs the identified risk and Herzuma should be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Herzuma?

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

Other information about Herzuma

The European Commission granted a marketing authorisation valid throughout the European Union for Herzuma on 9 February 2018.

For more information about treatment with Herzuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Herzuma : EPAR - Summary for the public BG = bălgarski 2018-05-17  
Herzuma : EPAR - Summary for the public ES = español 2018-05-17  
Herzuma : EPAR - Summary for the public CS = čeština 2018-05-17  
Herzuma : EPAR - Summary for the public DA = dansk 2018-05-17  
Herzuma : EPAR - Summary for the public DE = Deutsch 2018-05-17  
Herzuma : EPAR - Summary for the public ET = eesti keel 2018-05-17  
Herzuma : EPAR - Summary for the public EL = elliniká 2018-05-17  
Herzuma : EPAR - Summary for the public EN = English 2018-05-17  
Herzuma : EPAR - Summary for the public FR = français 2018-05-17  
Herzuma : EPAR - Summary for the public IT = italiano 2018-05-17  
Herzuma : EPAR - Summary for the public LV = latviešu valoda 2018-05-17  
Herzuma : EPAR - Summary for the public LT = lietuvių kalba 2018-05-17  
Herzuma : EPAR - Summary for the public HU = magyar 2018-05-17  
Herzuma : EPAR - Summary for the public MT = Malti 2018-05-17  
Herzuma : EPAR - Summary for the public NL = Nederlands 2018-05-17  
Herzuma : EPAR - Summary for the public PL = polski 2018-05-17  
Herzuma : EPAR - Summary for the public PT = português 2018-05-17  
Herzuma : EPAR - Summary for the public RO = română 2018-05-17  
Herzuma : EPAR - Summary for the public SK = slovenčina 2018-05-17  
Herzuma : EPAR - Summary for the public SL = slovenščina 2018-05-17  
Herzuma : EPAR - Summary for the public FI = suomi 2018-05-17  
Herzuma : EPAR - Summary for the public SV = svenska 2018-05-17  
Herzuma : EPAR - Summary for the public HR = Hrvatski 2018-05-17  

This EPAR was last updated on 28/05/2018 .

Authorisation details

Product details

Product details for Herzuma
NameHerzuma
Agency product numberEMEA/H/C/002575
Active substance

trastuzumab

International non-proprietary name (INN) or common name

trastuzumab

Therapeutic area Stomach NeoplasmsBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XC03
Additional monitoring

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

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Herzuma
Marketing-authorisation holder

Celltrion Healthcare Hungary Kft.

Revision1
Date of issue of marketing authorisation valid throughout the European Union09/02/2018

Contact address:

Celltrion Healthcare Hungary Kft.
Vaci ut 1-3
WestEnd Office Building B torony
1062 Budapest 
Hungary

Product information

Product information

15/03/2018  Herzuma -EMEA/H/C/002575 -IB/0002

Name Language First published Last updated
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28
Herzuma : EPAR - Product Information HR = Hrvatski 2018-05-17 2018-05-28

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  
Herzuma : EPAR - All Authorised presentations HR = Hrvatski 2018-05-17  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Metastatic breast cancer

Herzuma 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

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

Herzuma 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

Herzuma 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.

Herzuma 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Herzuma : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2018-05-28  

Initial marketing-authorisation documents

Name Language First published Last updated
Herzuma : EPAR - Public assessment report HR = Hrvatski 2018-05-17  
CHMP summary of positive opinion for Herzuma HR = Hrvatski 2017-12-15  

Authorised

This medicine is approved for use in the European Union

Related content