EC approves Henlius and Organon’s Poherdy biosimilar for HER2-positive breast cancer

Edited by Robert McTiernan··2 min read

Shanghai Henlius Biotech and Organon announced that the European Commission has granted marketing authorization for Poherdy (pertuzumab), making it the first approved biosimilar to Perjeta (pertuzumab) in Europe. The authorization covers all indications held by the reference product and marks a regulatory milestone for both companies in the HER2-positive breast cancer treatment space.

Poherdy is approved as a 420 mg/14 mL injection for intravenous use. In the metastatic setting, it is indicated in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. In the early breast cancer setting, the authorization covers neoadjuvant treatment of adults with HER2-positive locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence, as well as adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

The EC approval was based on a data package encompassing structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies. The totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data, was used to demonstrate that Poherdy is highly similar to the reference product. No single pivotal trial identifier was cited in the approval announcement, as the biosimilar pathway relies on this multi-component comparability framework rather than a standalone Phase III efficacy trial.

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Pertuzumab, which targets domain II of the HER2 extracellular region and blocks ligand-dependent HER2 dimerization, has been a standard component of HER2-directed regimens since Perjeta’s original authorization. Roche’s reference product remains widely used across neoadjuvant, adjuvant, and metastatic breast cancer settings in Europe, where breast cancer is the most commonly diagnosed cancer among women in the European Union according to European Commission data cited by the companies. The entry of the first pertuzumab biosimilar into the European market introduces a new pricing dynamic into those treatment pathways, though the commercial trajectory will depend on national-level reimbursement decisions across EU member states.

For Henlius, the EC authorization follows the company’s earlier US FDA approval of Poherdy as the first pertuzumab biosimilar in the United States, extending the asset’s regulatory footprint across two major markets. For Organon, which holds exclusive commercialization rights outside China under a license and supply agreement signed with Henlius in 2022, the approval adds to a biosimilars portfolio that the company has positioned as central to its women’s health strategy.

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