Palbociclib Viatris

Opinion

EMA has issued an opinion on this medicine

palbociclib

Overview

On 23 April 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 Palbociclib Viatris, intended for the treatment of locally advanced or metastatic breast cancer.

The applicant for this medicinal product is Viatris Limited.

Palbociclib Viatris will be available as 75 mg, 100 mg and 125 mg film-coated tablets. The active substance of Palbociclib Viatris is palbociclib, an antineoplastic agent, protein kinase inhibitor (ATC code: L01EF01). Palbociclib is a highly selective, reversible inhibitor of cyclin‑dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways which lead to cellular proliferation.

Palbociclib Viatris is a generic of Ibrance, which has been authorised in the EU since 9 November 2016. Studies have demonstrated the satisfactory quality of Palbociclib Viatris, and its bioequivalence to the reference product Ibrance.

The full indication will be as follows:

Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer.

• in combination with an aromatase inhibitor;
• in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).

In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

Treatment with Palbociclib Viatris should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

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 Palbociclib Viatris

Adopted Reference Number: EMA/84334/2026

Product details

• Name of medicine:
  Palbociclib Viatris
• Active substance:
  Palbociclib
• International non-proprietary name (INN) or common name:
  palbociclib
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01EF01
• EMA product number:
  EMEA/H/C/006624
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Viatris Limited
• Opinion adopted:
  23/04/2026
• Opinion status:
  Positive