Europe Approves First Perjeta Biosimilar, POHERDY, for Breast Cancer

SHANGHAI – April 29, 2026 – In a landmark decision for oncology care in Europe, the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab), the first-ever biosimilar to Roche's widely used breast cancer drug, PERJETA. Developed by Shanghai Henlius Biotech and commercialized by Organon, the approval marks a pivotal moment in the treatment of HER2-positive breast cancer, promising to increase patient access and introduce significant cost-saving competition into a multi-billion-euro market.

The authorization covers all indications of the reference product, making POHERDY a new option for patients with HER2-positive metastatic or early-stage breast cancer. This green light from the EC follows a similar first-in-market approval by the U.S. Food and Drug Administration (FDA), cementing the drug's position as a key global biosimilar.

A New Era for Breast Cancer Treatment Access

The arrival of POHERDY is poised to have a profound impact on healthcare systems across the European Union, where breast cancer stands as the most commonly diagnosed cancer among women. Biosimilars are highly similar, rigorously tested versions of original biologic medicines that are introduced after the originator's patents expire. Their primary benefit is fostering competition, which typically drives down prices and makes expensive, life-saving therapies more accessible.

"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," said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon. He emphasized that the move reinforces Organon's commitment to "supporting the sustainability of health care systems while advancing women's health through access to quality medicines."

This impact on sustainability is not trivial. Since 2006, the adoption of various biosimilars across Europe has generated an estimated €56 billion in cumulative cost reductions for healthcare systems. The introduction of biosimilars for other major oncology drugs, such as trastuzumab (Herceptin), has already saved billions, freeing up vital funds to treat more patients or invest in new healthcare innovations. The entry of POHERDY is expected to continue this trend, offering a more affordable yet equally effective alternative to PERJETA, which recorded global sales in the billions of euros annually.

The Strategic Alliance Powering Global Reach

This European milestone is the latest success for the strategic partnership between Henlius, a rapidly growing Chinese biopharmaceutical innovator, and Organon, a global healthcare company with a focus on women's health. The collaboration, established through a 2022 license and supply agreement, grants Organon exclusive global commercialization rights to POHERDY outside of China.

The approval serves as a powerful validation of Henlius's 'Globalisation 2.0' strategy. The Shanghai-based company has successfully transitioned from a domestic player to a global force, achieving profitability while doubling its overseas revenue year-over-year in 2025. With ten products now marketed in over 60 countries, Henlius is leveraging its robust R&D and manufacturing platform to compete in major international markets.

"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," stated Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system."

For Organon, POHERDY strengthens its burgeoning biosimilar franchise and directly aligns with its core mission. By adding a critical oncology biosimilar to its portfolio, the company is not only diversifying its revenue streams but also making a tangible impact on a disease that disproportionately affects women.

Navigating a Competitive and Evolving Market

POHERDY enters a dynamic and highly competitive HER2-positive breast cancer market. For years, the standard of care has been dominated by Roche's foundational therapies, Herceptin (trastuzumab) and Perjeta (pertuzumab), often used in combination with chemotherapy. More recently, the landscape has been reshaped by highly effective antibody-drug conjugates (ADCs) like AstraZeneca and Daiichi Sankyo's Enhertu, which has set new efficacy benchmarks.

While POHERDY is the first pertuzumab biosimilar to cross the finish line in Europe, it will not be the last. Several other companies, including a partnership between Sandoz and EirGenix, have rival biosimilars in late-stage development. This impending wave of competition is expected to further intensify price pressures on the reference product and drive broader adoption of biosimilar alternatives across the continent.

The approval was granted based on a comprehensive review of data demonstrating POHERDY's high similarity to PERJETA. This "totality of evidence" approach, which includes analytical, pharmacokinetic, and clinical studies, provides assurance to clinicians and patients that the biosimilar offers the same efficacy and safety profile as the originator drug. POHERDY is indicated for use in combination with trastuzumab and chemotherapy in both the neoadjuvant (before surgery) and adjuvant (after surgery) settings for early breast cancer, as well as for metastatic breast cancer.

While the EMA's centralized approval is a critical step, the final pace of adoption will depend on decisions made at the national level. Health technology assessment (HTA) bodies in individual EU member states will evaluate POHERDY's cost-effectiveness to determine reimbursement policies. However, with established frameworks designed to leverage the cost savings from biosimilars, POHERDY is well-positioned to be rapidly integrated into clinical practice, ultimately expanding the arsenal of affordable, effective treatments available to women fighting HER2-positive breast cancer.