Pebrilzo

Opinion

EMA has issued an opinion on this medicine

pertuzumab

Overview

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pebrilzo, intended for the treatment of breast cancer.

The applicant for this medicinal product is Biocon Biologics Ireland Limited.

Pebrilzo will be available as 420 mg concentrate for solution for infusion. The active substance of Pebrilzo is pertuzumab, a monoclonal antibody (ATC code: L01FD02) that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2.

Pebrilzo is a biosimilar medicinal product. It is highly similar to the reference product Perjeta (pertuzumab), which was authorised in the EU on 4 March 2013. Data show that Pebrilzo has comparable quality, safety and efficacy to Perjeta (pertuzumab).

The full indication is:

Early breast cancer

Pebrilzo 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 (see section 5.1)
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)

Metastatic breast cancer

Pebrilzo 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.

Treatment with Pebrilzo should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Pebrilzo should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately available.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Pebrilzo

Adopted Reference Number: EMA/CHMP/195428/2026

Product details

• Name of medicine:
  Pebrilzo
• Active substance:
  pertuzumab
• International non-proprietary name (INN) or common name:
  pertuzumab
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01FD02
• EMA product number:
  EMEA/H/C/006844
• 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 applicant:
  Biosimilar Collaborations Ireland Limited
• Start of evaluation:
  17/09/2026
• Opinion status:
  Positive