First Pertuzumab Biosimilar Approved, Promising Lower Costs for Breast Cancer Treatment

NEW YORK, NY – November 17, 2025 – The U.S. Food and Drug Administration (FDA) has approved POHERDY (pertuzumab-dpzb), a biosimilar to PERJETA (pertuzumab), for the treatment of HER2-positive breast cancer. This marks the first biosimilar version of pertuzumab available in the United States, with experts predicting this will significantly increase access to a critical oncology treatment and lower healthcare costs.

Expanding Access and Affordability in Oncology

The approval of POHERDY represents a turning point in the landscape of breast cancer treatment, particularly for patients who rely on HER2-targeted therapies. HER2-positive breast cancer, while treatable, often requires expensive and complex treatment regimens. Biosimilars like POHERDY offer a potentially more affordable alternative without compromising on quality or efficacy. “The introduction of biosimilars is crucial for driving down the overall cost of cancer care,” explained a healthcare economist familiar with biosimilar adoption. “These therapies provide a competitive pressure that can lead to substantial savings for patients and the healthcare system.”

While specific pricing for POHERDY hasn’t yet been publicly announced, industry analysts anticipate a significant discount compared to the reference product, PERJETA. Historically, biosimilars have launched with price reductions ranging from 30% to 70%, offering substantial savings to patients and payers. This expected price reduction is particularly welcome given the rising costs of cancer treatment and the financial burden faced by many patients and families.

Henlius and Organon: A Global Collaboration

The development and approval of POHERDY is the result of a strategic collaboration between Shanghai Henlius Biotech, Inc. and Organon. Henlius, a global biopharmaceutical company focused on biologics, developed the biosimilar, while Organon will commercialize it in the U.S. and other territories outside of China. This partnership underscores the growing trend of international collaboration in the development and commercialization of biosimilars.

The agreement between the two companies, finalized in June 2022, included an upfront payment and potential milestone payments totaling hundreds of millions of dollars. This financial commitment reflects the significant potential of POHERDY and the broader biosimilars market. A financial analyst following Organon stated, “This deal highlights Organon’s commitment to expanding its biosimilar portfolio and capitalizing on the growing demand for affordable cancer therapies.” Henlius’ success with POHERDY also solidifies its position as a leading global player in the biosimilars industry.

Interchangeability and Market Dynamics

A key factor driving the potential success of POHERDY is its designation as an interchangeable biosimilar. This means that, subject to state pharmacy laws, pharmacists can substitute POHERDY for PERJETA without the need for a physician’s approval. This streamlined substitution process is expected to accelerate adoption and increase access for patients. “Interchangeability is a game-changer for biosimilar uptake,” explained an oncologist involved in clinical trials. “It removes a significant barrier to access and allows more patients to benefit from these cost-effective therapies.”

However, despite the potential benefits, challenges remain in achieving widespread biosimilar adoption. Factors such as physician familiarity, patient perceptions, and payer policies can influence uptake rates. Education and awareness campaigns are crucial for addressing these challenges and ensuring that patients and healthcare professionals understand the benefits of biosimilars. While POHERDY is the first pertuzumab biosimilar approved in the US, the HER2-positive breast cancer market is becoming increasingly competitive, with Roche, the originator of PERJETA, promoting its fixed-dose combination of pertuzumab and trastuzumab, Phesgo. This adds another layer to the dynamics, requiring Organon to strategically position POHERDY within the competitive landscape.

The approval of POHERDY is expected to spark further competition within the market, ultimately benefiting patients through lower costs and increased access to life-saving therapies. The HER2-positive breast cancer treatment market, valued at over $10 billion globally, is expected to continue growing in the coming years, creating opportunities for both originator companies and biosimilar manufacturers.