EC Approves POHERDY as First PERJETA Biosimilar in Europe

Key Facts

The European Commission has granted marketing authorization for POHERDY (pertuzumab), developed by Henlius and Organon, marking it as the first biosimilar to Roche's PERJETA approved in the European market. This breakthrough treatment is indicated for breast cancer, providing a new therapeutic option for patients across the continent. The approval follows rigorous clinical data demonstrating biosimilarity and comparable efficacy to the reference product. By securing this authorization, Organon and Henlius establish a significant first-mover advantage in the European biosimilar space for this specific molecule. This regulatory milestone is expected to enhance patient access to critical oncology treatments while potentially reducing healthcare costs. The move underscores both companies' strategic commitment to expanding their presence in the high-growth biosimilars sector.