Henlius and Organon secure EC approval for POHERDY, Europe’s first Pertuzumab biosimilar

Shanghai Henlius Biotech and Organon (NYSE:OGN) announced on Wednesday, April 29, 2026, that the European Commission (EC) has granted marketing authorization for POHERDY (pertuzumab), making it the first and only approved biosimilar to the reference product PERJETA in Europe.

The authorization covers a 420 mg/14 mL injection for intravenous use across all indications previously held by the reference product.

The approval represents a significant expansion of treatment options for HER2-positive breast cancer, the most frequently diagnosed cancer among women in the European Union.

POHERDY is indicated for use in combination with trastuzumab and chemotherapy for adult patients with metastatic, inflammatory, or early-stage breast cancer at high risk of recurrence.

The EC’s decision follows a similar milestone in the United States, where POHERDY was also the first pertuzumab biosimilar to receive FDA approval.

The EC based its authorization on a comprehensive data package demonstrating that POHERDY is highly similar to the reference biological medicine.

The submission included comparative clinical studies and pharmacokinetic data confirming the biosimilar's equivalence in terms of efficacy, safety, and immunogenicity.

The commercialization of POHERDY is governed by a 2022 license and supply agreement, which granted Organon exclusive global commercialization rights to several of Henlius' biosimilars, excluding the China market.

For Henlius, the approval serves as a testament to its technical platform and international partnership strategy.