European Commission Approves POHERDY as First PERJETA Biosimilar in Europe

The European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab), a biosimilar developed by Shanghai Henlius Biotech, Inc. And Organon, making it the first biosimilar to PERJETA (pertuzumab) approved in Europe. The approval covers all indications of the reference product, offering a new treatment option for HER2-positive breast cancer.

The announcement, made on April 29, 2026, signifies a key milestone in expanding access to treatments for patients with HER2-positive breast cancers, a disease that represents the most commonly diagnosed cancer among women in the European Union. This follows POHERDY’s prior approval by the U.S. Food and Drug Administration (FDA) as the first pertuzumab biosimilar in the United States.

“As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union,”

Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon

POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease. The biosimilar is also approved for use in combination with trastuzumab and chemotherapy in the neoadjuvant and adjuvant treatment of early-stage HER2-positive breast cancer at high risk of recurrence, according to the European Medicines Agency (EMA).

According to the EMA, POHERDY has demonstrated comparable quality, safety, and efficacy to the reference product, PERJETA. The agency’s positive opinion, adopted on February 26, 2026, recommended the granting of a marketing authorization for the biosimilar.

“Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon,”

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius

Henlius and Organon emphasized their commitment to expanding access to treatment options for patients and supporting the sustainability of healthcare systems. Organon highlighted its growing global portfolio of biosimilars as reinforcing its dedication to advancing women’s health through access to quality medicines.

The approval of POHERDY represents a significant step forward in the biosimilar market, potentially lowering treatment costs and increasing patient access to a vital medication for HER2-positive breast cancer. Biosimilars are designed to be highly similar to existing biologic drugs, offering comparable efficacy and safety at a lower price point.

POHERDY will be available as a 420 mg concentrate for solution for infusion. Treatment with POHERDY must be initiated under the supervision of a physician experienced in administering anti-cancer agents.