The positive opinion follows the review of a marketing authorisation application submitted by Biocon Biologics Ireland, an indirect wholly owned subsidiary of Biocon Biologics.

Biocon said its Pertuzumab biosimilar is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA's tailored clinical development approach. The company said the application was supported by structural and functional analytical characterisation and comparative clinical pharmacokinetic data.

The European Commission will now conduct the final review and decide on marketing authorisation. Biocon said Pebrilzo is not authorised for use in the European Union until marketing authorisation is granted.

Pebrilzo contains Pertuzumab, a monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2). It is indicated for use with Trastuzumab and chemotherapy in certain patients with HER2-positive early-stage or locally advanced breast cancer. It is also indicated with Trastuzumab and Docetaxel for certain patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.

Biocon said comparative analytical and clinical pharmacokinetic data demonstrated high similarity between Pebrilzo and the reference biologic, with no clinically meaningful differences in quality, safety or efficacy.

Biocon is a Bengaluru-based biopharmaceutical company focused on biosimilars and generic medicines, with operations across more than 120 countries.

The company had reported 355% jump in consolidated net profit to Rs 141 crore in Q1 FY27 from Rs 31 crore in Q1 FY26. Revenue from operations rose by 10% year-on-year (YoY) to Rs 4,336 crore during the period under review.