China-based biopharmaceutical company Shanghai Henlius Biotech Inc (HK:2696) and US healthcare company Organon (NYSE:OGN) announced on Wednesday that the European Commission has approved POHERDY (pertuzumab), the first biosimilar to PERJETA in Europe, for all indications of the reference product.

The intravenous therapy is authorised for use in combination regimens to treat adults with HER2-positive breast cancer across metastatic, early-stage, and high-risk settings.

This approval expands access to treatment options for HER2-positive breast cancer, the most commonly diagnosed cancer among women in the European Union, according to the companies. POHERDY was previously approved in the United States as the first pertuzumab biosimilar, reinforcing the partners' global biosimilars portfolio.

Regulatory clearance was supported by a comprehensive data package, including analytical, pharmacokinetic, and comparative clinical studies demonstrating similarity to the reference biologic across efficacy, safety, and immunogenicity measures.

Under a 2022 agreement, Organon holds exclusive global commercialisation rights to POHERDY and other biosimilars developed by Henlius, excluding China.