Henlius and Organon Gain EC Approval for Pertuzumab Biosimilar

The European Commission (EC) has granted marketing authorization for a pertuzumab biosimilar named Poherdy, developed by Shanghai Henlius Biotech (Henlius) and commercialized in partnership with Organon, Henlius announced on April 29, 2026. Poherdy references Roche’s Perjeta (pertuzumab).¹

The approval marks the first for a pertuzumab biosimilar in Europe, according to Henlius. The therapy is authorized for all indications of the reference biologic, including treatment of HER2-positive breast cancer across metastatic and early disease settings.

The approval also reflects continued expansion of biosimilars into oncology, for which biologic therapies have historically driven high treatment costs. As breast cancer remains one of the most commonly diagnosed cancers among women in Europe, the introduction of biosimilar options may influence both treatment accessibility and healthcare system sustainability.²

What does the first pertuzumab biosimilar approval mean for HER2-positive breast cancer treatment?

Poherdy is indicated for use in combination with trastuzumab and chemotherapy in multiple clinical settings, including metastatic, neoadjuvant, and adjuvant treatment of HER2-positive breast cancer. These indications align with those of the reference product, supporting continuity in clinical practice while potentially expanding treatment access.

The approval was based on a comprehensive data package that demonstrated biosimilarity across analytical, pharmacokinetic, efficacy, safety, and immunogenicity measures. Such totality-of-evidence approaches are standard for biosimilar approvals and are designed to confirm that the biosimilar performs comparably to the originator biologic without clinically meaningful differences.³

“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 and the leading cause of cancer related deaths among women in the European Union [EU],” said Joe Azzinaro, vice president, Global Commercial Lead Biosimilars, Organon, in a company press release.¹

How could biosimilars influence oncology market dynamics?

The introduction of biosimilars into established oncology regimens may increase competition with reference biologics, potentially leading to pricing adjustments and broader patient access. In Europe, biosimilar adoption has historically contributed to cost savings and increased treatment uptake, particularly in therapeutic areas such as oncology and immunology.⁴

“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,” said Ping Cao, chief business development officer and senior vice president, Henlius, in the release.¹

What is the broader significance for global biosimilar development?

The approval of a pertuzumab biosimilar in Europe may indicate continued maturation of the global biosimilars market, particularly in complex oncology biologics. As more high-value biologics approach patent expiration, manufacturers are increasingly targeting therapies with established clinical use and significant market share.⁵

Henlius and Organon’s collaboration, which grants Organon commercialization rights outside of China, reflects a growing trend of cross-regional partnerships aimed at expanding global market access. Such agreements may enable more efficient distribution and regulatory navigation across diverse healthcare systems.¹

From an industry perspective, the expansion of biosimilars into targeted oncology therapies could influence future development priorities and competitive dynamics. While biosimilars are expected to play an increasing role in improving access to biologic treatments, their long-term impact will depend on adoption patterns, regulatory frameworks, and continued evidence generation in clinical practice.²

References

1. Shanghai Henlius Biotech. European Commission (EC) approves Henlius and Organon’s POHERDY (pertuzumab), the first approved biosimilar to PERJETA (pertuzumab) in Europe. Published April 29, 2026. Accessed April 29, 2026. https://www.henlius.com/en/NewsDetails-5880-26.html
2. Biosimilars: expanding access to essential biologic therapies. World Health Organization. Feb. 13, 2025. Accessed April 29, 2026. https://www.who.int/news/item/13-02-2025-biosimilars--expanding-access-to-essential-biologic-therapies
3. EMA. Biosimilar medicines: Overview. Accessed April 29, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview
4. Haustein R, de Millas C,Höer A, Häussler B. Saving money in the European healthcare systems with biosimilars. GaBI Journal 2012;1(3-4).120-126. doi: 10.5639/gabij.2012.0103-4.036
5. Goode R, Feldman WB, Tu SS. Ancillary product patents to extend biologic patent life. JAMA. 2023;330(21):2117-2119. doi: 10.1001/jama.2023.19547