POHERDY Biosimilar Approved in Europe
Analysis based on 6 articles · First reported Apr 29, 2026 · Last updated Apr 29, 2026
The approval of POHERDY by the International — European Commission is expected to positively impact the pharmaceutical market by increasing competition in the HER2-positive breast cancer treatment segment, potentially leading to lower costs and broader patient access. This development is favorable for Shanghai Henlius Biotech and Organon & Co., as it expands their market reach and strengthens their biosimilar portfolios.
The International — European Commission has granted marketing authorization for POHERDY (pertuzumab), a biosimilar developed by Shanghai Henlius Biotech and Organon & Co. This approval makes POHERDY the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, covering all indications of the reference product for HER2-positive breast cancer. This milestone follows POHERDY's prior approval by the United States — Food and Drug Administration and is expected to expand access to treatment options for patients in the European Union, while also supporting the sustainability of healthcare systems through potentially lower costs. The approval was based on a comprehensive data package reviewed by the European Union — European Medicines Agency, demonstrating POHERDY's high similarity to the reference product in terms of analytical, pharmacokinetic, efficacy, safety, and immunogenicity data.
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