European commission approves first pertuzumab biosimilar in europe

The European Commission has granted marketing authorization for POHERDY (pertuzumab), making it the first approved biosimilar to PERJETA (pertuzumab) in Europe. The drug was developed by Shanghai Henlius Biotech and will be commercialized by Organon (NYSE: OGN).

POHERDY is a 420 mg/14 mL injection approved for all indications of the reference product. The drug is indicated for treating adults with HER2-positive breast cancer in combination with trastuzumab and other therapies, including metastatic or locally recurrent unresectable cases where patients have not received previous anti-HER2 therapy or chemotherapy.

The approval covers neoadjuvant and adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence when used with trastuzumab and chemotherapy. The European Commission based its decision on comprehensive data including structural, functional, clinical pharmacokinetic, efficacy, safety, and immunogenicity studies demonstrating similarity to the reference product.

Under a 2022 license and supply agreement, Organon holds exclusive global commercialization rights for POHERDY except in China. The biosimilar previously received FDA approval in the United States.

Breast cancer represents the most commonly diagnosed cancer among women in the European Union, according to the companies' statement based on European Commission data.

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