On September 22, 2026, Biocon Biologics Limited (“Biocon”) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending marketing authorization for PEBRILZO® (pertuzumab), its biosimilar to Genentech’s PERJETA®.
According to Biocon, PEBRILZO® is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA’s tailored clinical development approach. The company reported that extensive structural and functional analytical characterization, together with comparative clinical pharmacokinetic data, demonstrated biosimilarity to the reference product, with no clinically meaningful differences in quality, safety, or efficacy.
PEBRILZO® is proposed as a 420 mg concentrate solution for infusion. The recommended indications include use with trastuzumab and chemotherapy for neoadjuvant treatment of certain adults with HER2-positive breast cancer at high risk of recurrence, and for adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence. The recommendation also covers use with trastuzumab and docetaxel for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
The application now awaits a decision from the European Commission. The positive CHMP opinion does not constitute marketing authorization, and PEBRILZO® is not authorized for use in the European Union pending that decision.
Biocon’s pertuzumab biosimilar has not yet been approved by the FDA.
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