Major oncology milestone as Organon and Henlius secure FDA approval for POHERDY, the first U.S. biosimilar to PERJETA

The U.S. Food and Drug Administration has approved POHERDY (pertuzumab-dpzb), marking the first time an interchangeable biosimilar to PERJETA (pertuzumab) has been authorized in the United States for the treatment of HER2-positive breast cancer. The approval was announced by Shanghai Henlius Biotech, Inc. and Organon & Co., which holds global commercialization rights excluding China, outlining a significant turning point in the competitive oncology market for biologics addressing one of the most aggressive forms of breast cancer. The companies emphasized that the decision may reshape access, affordability, and institutional prescribing behavior in a category historically dominated by the reference product developed by Genentech, a member of the Roche Group. The FDA determined that POHERDY is interchangeable with PERJETA, meaning it may be substituted at the pharmacy level subject to state laws, marking an additional milestone that few oncology biosimilars have reached.

The therapy is approved for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer as well as those with HER2-positive early breast cancer in neoadjuvant and adjuvant settings. According to statements by Organon and Henlius, clinical, structural, and pharmacokinetic data demonstrated high similarity to the reference product, with no clinically meaningful differences in safety, purity, or potency. These regulatory conclusions reflect the maturation of the U.S. biosimilars framework and signal growing FDA confidence in interchangeability standards for complex oncology biologics.

Why the first pertuzumab biosimilar approval may reset oncology drug costs and access for HER2-positive breast cancer patients in the United States

The arrival of the first pertuzumab biosimilar raises consequential questions about pricing pressure, treatment availability, and insurer reimbursement strategies. PERJETA has been a cornerstone of HER2-directed therapy, often prescribed alongside trastuzumab-based regimens. With POHERDY, payers may see new negotiating leverage on pharmaceutical expenditures, particularly as HER2-positive breast cancer accounts for roughly 15% to 20% of breast cancer cases in the U.S., representing a substantial patient base. Health policy analysts have frequently noted that biosimilars can lower oncology treatment costs over time, though the rate of price compression varies significantly depending on competitive activity and formulary decisions.

Industry observers have stated that the interchangeability designation could accelerate adoption, since healthcare providers and pharmacists may have more flexibility in substituting POHERDY for PERJETA in certain states. While biosimilars have gained broad traction in Europe, the U.S. market has historically experienced a slower uptake. The approval of POHERDY may serve as a case study in how high-value oncology biologics respond to biosimilar entry and how hospitals and integrated delivery networks incorporate biosimilars into treatment pathways.

How Organon’s commercialization rights for POHERDY may influence institutional sentiment for its biosimilars strategy and future market expansion

Organon & Co. (NYSE: OGN), which was spun out from Merck in 2021 with a portfolio focus on women’s health, established a licensing agreement with Henlius that gives it exclusive worldwide commercialization rights for POHERDY outside China. Market analysts have suggested that the FDA approval may reinforce credibility in Organon’s biosimilars business, which the company has repeatedly described as an engine of strategic diversification. Organon has insisted that biosimilars represent an avenue to expand access and support sustainable healthcare systems, particularly in oncology, immunology, and women’s health.

According to available price and data analytics, shares of Organon have traded in a range that reflects both restructuring challenges and investor anticipation for pipeline expansion. Organon & Co. (OGN) is a equity in the USA market. The price is 7.655 USD currently with a change of 0.12500 (0.01660%) from the previous close. The intraday high is 7.9 USD and the intraday low is 7.375 USD. The latest open price was 7.53 USD and the intraday volume is 4370916. The latest trade time is Monday, November 17, 20:52:58 UTC. The sentiment among institutional market participants appears cautiously optimistic, with some analysts stating that biosimilar oncology assets may help improve revenue stability beyond 2026 if adoption meets projections. Other commentators have raised questions about commercialization execution and competitive response timelines from Roche.

What the first U.S. pertuzumab biosimilar could mean for Roche, Genentech, and innovation cycles in HER2-targeted cancer therapy

Roche and Genentech have long led the HER2 oncology market with a therapeutic lineup that includes PERJETA, Herceptin, and the fixed-dose combination formulation PHESGO. Industry experts have speculated that Roche’s strategic defense could include pricing modifications, contracting strategies, and increased emphasis on next-generation assets and subcutaneous regimens. Analysts also pointed out that PHESGO, which combines pertuzumab and trastuzumab in a single injection, could remain a competitive counterweight, as convenience and reduced chair time are considered increasingly important to oncology infusion centers.

Some oncology market researchers noted that with biosimilar competition emerging, companies operating in the HER2-targeted space may channel more resources into antibody-drug conjugates and precision oncology therapies. These include investigational pipeline approaches that seek to reduce resistance mechanisms and improve disease-free survival outcomes. Even in a more competitive biosimilar environment, originators generally maintain market presence through clinical differentiation or next-generation formulations, though pricing dynamics may evolve.

How the evolving U.S. biosimilars regulatory landscape could reshape access and affordability for complex biologics beyond breast cancer treatment

The FDA decision also highlights a broader regulatory evolution affecting immunology and oncology biosimilars. The agency has communicated that analytical rigor, comparative clinical evidence, and pharmacokinetic testing remain the foundation of biosimilar evaluation, while interchangeability designations require more specific switching data. Healthcare policy circles have indicated that the POHERDY approval may spur examination of reimbursement guidelines to ensure that biosimilar adoption does not create administrative complexity for health systems.

The approval may also strengthen international biosimilar collaboration, as Henlius continues expanding its global commercialization footprint for multiple monoclonal antibody therapies. The biosimilars market has entered a new period defined by loss of exclusivity across high-value biologics, including therapies for immune disorders, cancer, and rare diseases. With U.S. payers generally supportive of biosimilar adoption, the discussion now shifts toward real-world evidence, switching behavior, cost savings, and how quickly physician confidence accelerates usage.

Why physicians, advocacy groups, and treatment centers may watch early POHERDY adoption trends to understand therapeutic and economic outcomes

Patient advocacy organizations have frequently voiced support for biosimilars as a pathway to reducing out-of-pocket patient costs, especially for long-duration oncology regimens. Providers have emphasized that clinical stability and reliable supply chains are essential for treatment planning. Some oncology groups are likely to evaluate formulary integration models, assess reimbursement cycles, and work closely with pharmacists to determine appropriate substitution protocols. Academic cancer centers may monitor safety, tolerability, and real-world progression-free survival data, offering future insights into biosimilar utilization within complex combination therapies.

The introduction of an interchangeable pertuzumab biosimilar carries the potential to shift health-economic models in breast cancer therapy over the coming years. As the market absorbs competitive dynamics, analysts predict that additional entrants could further expand access and reduce cost burdens, though uptake timelines are often staggered across integrated delivery networks and regional payer systems. Advocacy groups are also expected to monitor insurance policies to ensure that substitution rules do not inadvertently restrict patient choice or delay treatment initiation. Some oncologists have indicated that educational efforts and clear clinical guidance will be key to helping patients and providers feel confident when transitioning from originator to biosimilar therapies, especially when treatments involve complex infusion scheduling. If POHERDY demonstrates sustained safety and clinical reliability in real-world settings, it could serve as a blueprint for biosimilar adoption across multiple oncology categories, encouraging manufacturers to pursue development of interchangeable options in other high-value biologic markets.