29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to Perjeta (pertuzumab) in Europe, for all indications of the reference product.

Poherdy was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that Poherdy is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).

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