Organon Gains Strategic Edge with FDA Approval of First PERJETA Biosimilar POHERDY
FDA Greenlights POHERDY: First US-Approved PERJETA Biosimilar Broadens Access to HER2-Positive Breast Cancer Treatments
Organon (NYSE: OGN) and Shanghai Henlius Biotech announced a breakthrough moment: the US Food and Drug Administration (FDA) has approved POHERDY (pertuzumab-dpzb), the first and only PERJETA (pertuzumab) biosimilar authorized in the United States for all existing indications. POHERDY is now positioned to provide patients with certain HER2-positive breast cancers a high-quality, potentially more affordable biologic therapy, making waves in women’s oncology treatment access.
What Makes This Approval Stand Out?
POHERDY’s FDA approval covers all approved uses of its reference product, including:
- Combination therapy for adults with HER2-positive metastatic breast cancer (MBC)
- Neoadjuvant and adjuvant treatment for HER2-positive early or locally advanced breast cancer
It’s the first time US patients will have an interchangeable, FDA-validated alternative to the brand name drug for these critical indications, with a comprehensive safety and efficacy record comparable to PERJETA. The move expands treatment choices and, according to Organon, supports the company’s mission to make care more sustainable for women facing breast cancer.
POHERDY at a Glance: Clinical Impact and Indications
| Indication | Therapy Setting | Key Points |
|---|---|---|
| Metastatic Breast Cancer (MBC) | First-line in combination with trastuzumab and docetaxel | For adults who haven’t received anti-HER2 or chemo for metastatic disease |
| Early Breast Cancer (EBC) | Neoadjuvant (pre-surgery) and adjuvant (post-surgery) in combination with trastuzumab and chemotherapy | Locally advanced, inflammatory, or high-risk early-stage, >2 cm or node positive |
Strategic Momentum: Organon’s Oncology Expansion
This approval doesn’t just enhance Organon’s product lineup—it strengthens their ability to compete in the high-stakes biosimilars market and brings a new level of optionality for prescribers. The Organon-Henlius partnership—originally sealed in 2022—covers exclusive global rights (excluding China) to commercialize multiple biosimilars. The companies believe POHERDY’s entry will accelerate their reach in oncology and set a new precedent in affordable biologics for the US.
Safety Considerations: Important to Know Before Prescribing
As with the reference product, POHERDY comes with critical safety and monitoring requirements:
- Cardiac Monitoring: Risks of left ventricular dysfunction and heart failure require regular assessment before and during therapy. Symptomatic heart failure in trials ranged from 0.6% to 4% depending on patient setting and regimen.
- Embryo-Fetal Toxicity: Serious fetal risks including embryo-fetal death and birth defects. Effective contraception during and for 7 months post-treatment is recommended.
- Infusion and Hypersensitivity Risks: Infusion reactions occurred in up to 21% of patients in clinical studies, though severe events were less than 1%.
- Most Common Adverse Reactions (=30% incidence): Diarrhea, alopecia, nausea, neutropenia, fatigue, rash, and peripheral neuropathy, varying by regimen and treatment stage.
Summary Table: Key Safety Observations from Clinical Trials
| Trial/Setting | LVEF Decline or Dysfunction (%) | Symptomatic Heart Failure (%) | Infusion Reactions (%) |
|---|---|---|---|
| CLEOPATRA (MBC) | 4-8 | 1 | 13 (first infusion) |
| TRYPHAENA (Neoadjuvant) | 7-16 | 0-4 | NA |
| APHINITY (Adjuvant) | 3 | 0.6 | 21 |
Industry Impact: Biosimilars Bring Competition and Affordability
With the FDA’s green light for POHERDY, the competitive dynamics for HER2-positive breast cancer treatments may shift, potentially improving affordability for US patients. While POHERDY must still navigate commercial and provider adoption, its similarity and interchangeability designation positions it as a meaningful option.
What Should Stakeholders Watch For Next?
The approval marks a critical milestone in biosimilar adoption, and could accelerate trends in market access, payer policy, and patient affordability. Investors, healthcare professionals, and patients may want to track commercial uptake, pricing decisions, and broader portfolio developments from Organon and Henlius. This approval’s ripple effect may signal a new era of biosimilar competition in oncology—and the potential for more cost-effective treatments on the horizon.
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