Tagged as: PEBRILZO

Genentech and Biocon Settle Pertuzumab Biosimilar BPCIA Litigation

On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar. The same day, Biocon announced that it had entered into a…

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Biocon’s Pertuzumab Biosimilar Receives Positive CHMP Opinion Under EMA’s Tailored Clinical Approach

Full frame of molecular structure of liquids in motion.

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…

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