EU Medicines Agency Panel Backs Approval of Biocon Biologics Ireland's Breast Cancer Biosimilar

07:56 AM EDT, 09/18/2026 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Biocon Biologics Ireland's Pebrilzo to treat breast cancer, according to a Friday release. The drug, which is a biosimilar to Roche's (RO.SW) Perjeta, is intended for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of human epidermal growth factor receptor 2-positive, locally advanced, inflammatory, or early stage breast cancer, as well as adjuvant treatment of adults with HER2-positive early breast cancer, both at high risk of recurrence. It is also indicated for use in combination with trastuzumab and docetaxel in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. The European Commission is expected to issue its final decision in the near future.