European Commission Approves POHERDY, First Pertuzumab Biosimilar in Europe by Henlius and Organon

Key Takeaways

• POHERDY becomes the first and only approved pertuzumab biosimilar in Europe, offering an alternative to PERJETA
• The approval covers all indications of the reference product, potentially improving patient access to cancer treatment
• Henlius Biotech and Organon partnership achieves significant regulatory milestone in European oncology market

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Historic Approval for Cancer Treatment Alternative

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced on April 29, 2026, that the European Commission has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection for intravenous use. This milestone makes POHERDY the first and only approved biosimilar to PERJETA (pertuzumab) in Europe.

Comprehensive Coverage Across Indications

The EC approval encompasses all indications of the reference product PERJETA, which is widely used in cancer treatment protocols. This comprehensive approval allows healthcare providers to substitute POHERDY across the full spectrum of pertuzumab applications, potentially offering cost savings while maintaining therapeutic efficacy.

Market Impact and Patient Access

The introduction of Europe’s first pertuzumab biosimilar represents a significant development in oncology care. Biosimilars typically offer more affordable alternatives to reference biologics, potentially improving patient access to essential cancer treatments. The approval strengthens the competitive landscape in the European oncology market and may influence pricing dynamics for pertuzumab-based therapies.

Partnership Achievement

The successful approval reflects the strategic collaboration between Henlius Biotech, a leading Chinese biopharmaceutical company, and Organon, a global healthcare company focused on women’s health. This partnership demonstrates the growing importance of international collaborations in bringing biosimilar medicines to market.

Regulatory Significance

The EC’s decision follows rigorous evaluation of POHERDY’s safety, efficacy, and quality compared to the reference product. This approval paves the way for potential submissions in other global markets and establishes POHERDY as a key player in the pertuzumab biosimilar space.

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Frequently Asked Questions

What does this approval mean for cancer patients in Europe?

Patients now have access to POHERDY as a biosimilar alternative to PERJETA, potentially offering the same therapeutic benefits at a lower cost, improving overall access to pertuzumab treatment.

When will POHERDY be available in European markets?

While the EC has granted marketing authorization, the exact launch timeline will depend on individual country implementations and commercial preparations by Henlius and Organon.

How does POHERDY compare to the original PERJETA?

As an approved biosimilar, POHERDY has demonstrated comparable safety, efficacy, and quality to PERJETA across all approved indications, meeting strict regulatory standards for biosimilarity.