Overview

Ogivri 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, Ogivri 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: with 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).

    Ogivri 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.

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

    Ogivri contains the active substance trastuzumab.

Ogivri 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 every week or every 3 weeks for breast cancer, and 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 Ogivri 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 Ogivri, see the package leaflet or contact your doctor or pharmacist.

The active substance in Ogivri, 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 Ogivri with Herceptin have shown that the active substance in Ogivri is highly similar to that in Herceptin in terms of structure, purity and biological activity. Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.

In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition. Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel). A response to treatment after 24 weeks was seen in 70% of the patients given Ogivri (160 of 230) and 64% of the patients given Herceptin (146 of 228). In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Ogivri would behave in the same way as Herceptin in its approved indications.

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

The safety of Ogivri 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 Ogivri are heart problems, reactions related to the infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.

Ogivri 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.

Ogivri 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, Ogivri 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 Ogivri infusion is equivalent to that of Herceptin infusion.

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

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

Ogivri received a marketing authorisation valid throughout the EU on on 12 December 2018.

Ogivri : EPAR - Medicine overview

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Ogivri : EPAR - Risk-management-plan summary

Product information

Ogivri : EPAR - Product information

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Latest procedure affecting product information: IAIN/0058

30/11/2023

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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).

Ogivri : EPAR - All authorised presentations

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Product details

Name of medicine
Ogivri
Active substance
trastuzumab
International non-proprietary name (INN) or common name
trastuzumab
Therapeutic area (MeSH)
  • Stomach Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC03

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Metastatic breast cancer

Ogivri 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                     

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

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

Metastatic gastric cancer

Ogivri 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 gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Ogivri 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/004916

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
Biosimilar Collaborations Ireland Limited

Unit 35/36
Grange Parade,
Baldoyle Industrial Estate
Dublin 13
DUBLIN
D13 R20R
Ireland

Opinion adopted
18/10/2018
Marketing authorisation issued
12/12/2018
Revision
11

Assessment history

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

Ogivri : EPAR - Public assessment report

CHMP summary of positive opinion for Ogivri

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