Poherdy
Authorised
This medicine is authorised for use in the European Union
pertuzumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Poherdy is a cancer medicine used to treat adults with certain types of HER2-positive breast cancer. HER2-positive means that the cancer cells produce a protein called HER2 in large quantities on their surface, which makes the tumour cells grow more quickly. It is used when the cancer is:
- metastatic (has spread to other parts of the body) or has come back locally after treatment and cannot be removed by surgery, in people who have not been treated with chemotherapy or medicines targeting HER2. In these cases, Poherdy is used with trastuzumab and docetaxel (other cancer medicines);
- locally advanced, inflammatory or early-stage breast cancer at high risk of coming back. In this case, Poherdy is used in combination with trastuzumab and chemotherapy before the patient undergoes surgery;
- early breast cancer at high risk of coming back. In this case, Poherdy is used in combination with trastuzumab and chemotherapy, after the patient has had surgery.
Poherdy contains the active substance pertuzumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Poherdy is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Poherdy is Perjeta. For more information on biosimilar medicines, see here.
Poherdy can only be obtained with a prescription. Treatment should be started under the supervision of a doctor experienced in using cancer medicines. It must be given by a doctor or nurse trained to manage severe allergic reactions, at a hospital where resuscitation equipment is readily available.
Poherdy is given by infusion (drip) into a vein every 3 weeks. The first infusion lasts one hour and following infusions last 30 minutes to 1 hour.
In people with early-stage or locally advanced breast cancer, those treated with Poherdy before surgery are given 3 to 6 infusions. In those treated after surgery, up to 18 infusions are given over a maximum of one year, unless the disease gets worse or unacceptable side effects occur. In people with metastatic breast cancer, treatment should continue unless the disease gets worse or unacceptable side effects occur.
For more information about using Poherdy, see the package leaflet or contact your doctor or pharmacist.
The active substance in Poherdy, pertuzumab, is a monoclonal antibody (a type of protein) designed to attach to HER2, a protein found on HER2-positive cancer cells. By attaching to HER2, pertuzumab stops it producing signals that cause the cancer cells to grow. It also activates cells of the immune system (the body’s natural defences), which then kill the cancer cells.
Laboratory studies comparing Poherdy with Perjeta have shown that the active substance in Poherdy is highly similar to that in Perjeta in terms of structure, purity and biological activity. Studies have also shown that giving Poherdy produces similar levels of the active substance in the body to those seen with Perjeta.
In addition, a main study involving 908 women with HER2-positive early-stage or locally advanced breast cancer compared Poherdy with Perjeta. Participants were treated with either Poherdy or Perjeta before surgery to remove the cancer. The main measure of effectiveness was the number of women with a ‘total pathological complete response’, meaning that there was no sign of cancer cells growing into the breast or nearby lymph nodes removed during surgery. About 46% (210 out of 454) of women treated with Poherdy and 46% (208 out of 454) of those treated with Perjeta achieved this response, indicating similar effectiveness.
Because Poherdy is a biosimilar medicine, the studies on the effectiveness of pertuzumab carried out with Perjeta do not all need to be repeated for Poherdy.
Studies carried out with Poherdy are described in more detail in the medicine’s assessment report.
The safety of Poherdy has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of Perjeta.
For the full list of side effects and restrictions of Poherdy, see the package leaflet.
The most common side effects with Poherdy (which may affect more than 3 in 10 people) include neutropenia (low levels of neutrophils, a type of white blood cell), diarrhoea, nausea (feeling sick), vomiting, hair loss and tiredness.
Some side effects can be serious. The most frequent (which may affect more than 1 in 10 people) include neutropenia with or without fever.
Poherdy must not be used in people with hereditary fructose intolerance, a rare genetic condition in which the body cannot break down fructose (a type of sugar).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Poherdy has a highly similar structure, purity and biological activity to Perjeta and is distributed in the body in the same way.
In addition, a study has shown that Poherdy and Perjeta are equivalent in terms of safety and effectiveness when used to treat people with HER2-positive early-stage or locally advanced breast cancer before surgery.
All these data were considered sufficient to conclude that Poherdy will have the same effects as Perjeta in its authorised uses.
Therefore, the Agency’s view was that, as for Perjeta, the benefits of Poherdy 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 Poherdy have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Poherdy are continuously monitored. Suspected side effects reported with Poherdy are carefully evaluated and any necessary action taken to protect patients.
Poherdy received a marketing authorisation valid throughout the EU on 23 April 2026.
Product information
Latest procedure affecting product information:VR/0000348769
21/05/2026
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).
Product details
- Name of medicine
- Poherdy
- Active substance
- pertuzumab
- International non-proprietary name (INN) or common name
- pertuzumab
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01FD02
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Early breast cancer
Poherdy is indicated for use in combination with trastuzumab and chemotherapy in:
- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
Metastatic breast cancer
Poherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
News on Poherdy
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