Henlius and Organon Announce U.S. FDA Approval of POHERDY®, the First Interchangeable Pertuzumab Biosimilar in the United States
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced a major regulatory milestone with the U.S. Food and Drug Administration’s (FDA) approval of the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb), a 420 mg/14 mL intravenous injection. The product has been granted approval as an interchangeable biosimilar to PERJETA® (pertuzumab) and is cleared for all licensed indications of the reference biologic. With this decision, POHERDY becomes the first—and currently only—pertuzumab biosimilar available in the United States, marking a pivotal moment in broadening patient access to high-quality biologic treatments for HER2-positive breast cancer.
This FDA decision not only underscores the increasing maturity of biosimilar development and regulatory pathways in oncology but also reinforces the importance of affordable treatment alternatives for common and life-impacting diseases. For patients with HER2-positive breast cancers—conditions where HER2 proteins are overexpressed and drive rapid tumor growth—pertuzumab-based therapies have become an essential cornerstone of care. Until now, PERJETA was the only pertuzumab option available in the U.S. marketplace. The arrival of an interchangeable biosimilar such as POHERDY is poised to introduce meaningful choice, potentially lowering overall treatment costs and expanding therapeutic accessibility.
Advancing Treatment Access for Women’s Health and Oncology
Jon Martin, U.S. Commercial Lead, Biosimilars and Established Brands at Organon, emphasized that the approval aligns directly with Organon’s mission to advance health equity, especially in conditions that disproportionately affect women.
“Expanding access to treatments for diseases that disproportionately impact women, including breast cancer—the most common cancer among women in the U.S., excluding skin cancer—is at the core of our mission,” Martin stated. He highlighted that POHERDY’s approval represents more than regulatory success; it augments Organon’s rapidly growing biosimilars portfolio and strengthens the company’s strategic commitment to women’s health and oncology.
Martin added that Organon’s partnership with Henlius has been instrumental in bringing high-quality biologic options to patients. Biosimilars, he noted, play a significant role in enhancing sustainability within the healthcare ecosystem. As biologic medicines continue to rise in cost, biosimilars provide a vital pathway to broaden availability without compromising safety, efficacy, or quality. With POHERDY now approved, Organon is positioned to further contribute to a competitive and more accessible biologics marketplace in the United States.
Henlius Celebrates a Cornerstone in Global Expansion
For Henlius, the FDA approval represents a significant achievement within its long-term global development strategy. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, described the approval as a historic milestone reflecting the company’s strengths in innovation, high-quality biologics development, and rigorous adherence to international regulatory standards.
“The FDA approval of POHERDY marks a significant milestone in Henlius’ global expansion and quality biologics development,” he said. “As the first pertuzumab biosimilar approved in the U.S., this important achievement demonstrates our core capability to build a sustainable global R&D system grounded in scientific rigor.”
Dr. Zhu further emphasized Henlius’ unwavering commitment to its patient-centric philosophy, focusing on expanding global access to high-quality therapeutics. He noted that the company will continue accelerating the development and delivery of cost-effective biologics designed to benefit patients worldwide. The approval, he added, reinforces Henlius’ reputation as a global innovator in biosimilar development.
Strengthening Collaboration to Expand Global Reach
Ping Cao, Chief Business Development Officer and Senior Vice President at Henlius, underscored how the approval also showcases the company’s growing expertise in international regulatory submissions and multinational commercialization partnerships.
“The approval of POHERDY further underscores Henlius’ track record in international registration, together with our strength in quality management and commercialization collaboration,” Cao remarked. She highlighted the strong collaboration with Organon as a key driver for global biosimilar expansion.
Henlius and Organon intend to leverage each other’s complementary capabilities—including robust manufacturing, supply chain efficiency, and deep market engagement—to ensure that POHERDY can rapidly reach patients. Cao expressed confidence that the two companies’ unified strengths in distribution and commercialization will broaden patient access while supporting healthcare systems with high-quality, affordable treatment options.
Indications and Clinical Use of POHERDY®
POHERDY is a HER2/neu receptor antagonist and is approved to be used in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Additionally, POHERDY is indicated for HER2-positive early-stage breast cancer in the following ways:
- Neoadjuvant Treatment
For adult patients with locally advanced, inflammatory, or early-stage breast cancer characterized by tumors larger than 2 cm in diameter or node-positive disease. It is administered in combination with trastuzumab and chemotherapy as part of a comprehensive treatment regimen designed to increase the likelihood of successful surgical outcomes and long-term disease control. - Adjuvant Treatment
For adults with HER2-positive early breast cancer who are at high risk of recurrence. When used in combination with trastuzumab, POHERDY helps reduce the risk of cancer returning after surgery.
These indications mirror those of the reference product, PERJETA, ensuring that clinicians have familiarity and confidence in the therapeutic roles POHERDY will serve.
Safety Considerations and Important Warnings
Like all pertuzumab-based therapies, POHERDY carries safety risks that clinicians must consider. The most critical include:
Cardiac Toxicity
Pertuzumab products can cause subclinical or clinical cardiac dysfunction, including decreased left ventricular ejection fraction (LVEF) and potential progression to congestive heart failure (CHF).
Clinicians are instructed to:
- Evaluate cardiac function prior to initiating treatment
- Monitor cardiac health throughout therapy
- Discontinue treatment if a clinically meaningful decline in LVEF is confirmed
Embryo-Fetal Toxicity
Exposure to pertuzumab during pregnancy can lead to embryo-fetal harm, including birth defects and fetal death. Patients must be:
- Informed of these risks
- Advised to use effective contraception during treatment and for a defined period afterward
Additional safety information accompanies the product labeling to guide oncologists and care teams in optimal monitoring and patient management.
Robust Data Package Supporting Approval
The FDA’s approval of POHERDY was built on an extensive evidence package, demonstrating with scientific rigor that the biosimilar matches its reference product in all critical dimensions. The submission included:
- Comprehensive analytical similarity data
Detailed molecular and structural analyses establishing that POHERDY is highly similar to PERJETA in terms of physicochemical properties. - Clinical pharmacokinetic (PK) studies
Designed to confirm similarity in exposure, distribution, metabolism, and clearance. - Comparative clinical studies
These evaluations reinforced that POHERDY and PERJETA exhibit comparable safety, purity, and potency, meeting all requirements for biosimilarity and interchangeability as defined under U.S. law.
Interchangeability status is particularly significant—it allows pharmacists, in many jurisdictions, to substitute POHERDY for PERJETA without prescriber intervention, subject to state laws. This designation is reserved for biosimilars that meet an even higher standard of similarity and therapeutic consistency.
A Strategic Partnership Strengthening Global Biosimilar Access
The approval is also a testament to the strategic collaboration between Henlius and Organon. In 2022, the companies entered into a license and supply agreement granting Organon exclusive commercialization rights for multiple biosimilars, including POHERDY, across global markets excluding China.
This partnership allows:
- Henlius to leverage its advanced manufacturing and R&D capabilities
- Organon to utilize its broad market presence, commercial expertise, and established infrastructure in women’s health and oncology
With POHERDY now FDA-approved, the companies’ combined oncology portfolio becomes stronger, enabling more patients in the U.S. to benefit from high-quality biologics.
The FDA approval of POHERDY® (pertuzumab-dpzb) stands as a landmark achievement for both Henlius and Organon and a transformative moment for the U.S. biosimilars landscape. As the first and only approved pertuzumab biosimilar in the United States—complete with interchangeability designation—POHERDY has the potential to influence the future of HER2-positive breast cancer treatment significantly.
The milestone reflects:
- The maturity and scientific excellence of Henlius’ global R&D capabilities
- Organon’s mission to expand access to essential women’s health therapies
- The ongoing evolution of the biosimilars market as a sustainable, affordable alternative for high-cost biologic treatments
Ultimately, the approval brings forward a new chapter in oncology care—one where more patients may gain access to life-changing therapies through the availability of high-quality, cost-effective biosimilars.
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