FDA Approves Poherdy, First Biosimilar to Perjeta, For HER2 Breast Cancer Indications

The FDA approved pertuzumab-dpzb (Poherdy; Shanghai Henlius Biologics Co. Ltd.), an interchangeable biosimilar to pertuzumab (Perjeta; Genentech). According to the FDA, this is the first approval of a biosimilar for Perjeta.¹

What are Biosimilars?

Biosimilars are biologic medications that are highly similar to biologics without having clinically meaningful differences from their reference products. They are often made with the same types of living sources and given to patients via the same mode of administration, have similar formulations and strengths, and have the same doses and treatment benefits while offering patients more affordable treatment options. Biologics cannot be copied exactly, even though the active ingredients in generic drugs are often smaller, simpler, and easier to copy.²

The biosimilar approval process is shorter because the treatment does not need to demonstrate superiority to its reference product, but instead, biosimilarity or clinical similarity. Essentially, the goal of these trials is to identify that the investigational treatment is similar to its reference product, moves through patients similarly, and is produced and structured in a similar fashion.²

Poherdy’s FDA Approval

Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. After an initial 840-mg loading dose, the 420-mg maintenance doses are administered every 3 weeks for 3 to 6 cycles in the neoadjuvant setting. The FDA recommends initial doses are administered over a 60-minute duration, and following infusions are administered over 30- to 60-minute time periods.^1,3

Poherdy is a HER2/neu receptor antagonist and is indicated for^1,3:

• Use in combination with trastuzumab (Herceptin; Genentech) and docetaxel for adults with HER2+ metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
• Use in combination with trastuzumab and chemotherapy as:
  • Neoadjuvant treatment of adults with HER2+, locally advanced, inflammatory, or early-stage breast cancer (either ≥2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
  • Adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

As an interchangeable biosimilar, Poherdy is structurally and functionally highly similar to its reference product, Perjeta, and demonstrates no clinically meaningful differences in safety, purity, or potency. Significantly, the interchangeability designation means that the biosimilar may be substituted for the reference product without consultation with the prescribing clinician; however, this is subject to state-specific pharmacy laws.

The FDA reported that the interchangeability designation was determined using the comprehensive "totality of the evidence" approach mandated by the FDA, including extensive analytical characterization, human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity data, and comparative clinical efficacy results.¹

The prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, as well as warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis, the FDA noted in their news release.¹

HER2-expressing breast cancers—including HER2+, HER2–, HER2-low, and HER2-ultralow—are relatively common, and account for approximately 20% of all breast cancer diagnoses. They are associated with increased risk of disease recurrence and poorer treatment responses, underscoring the importance of continued innovation in therapeutic approaches throughout the treatment plan as well as affordable treatment methods, such as biosimilars.⁴

REFERENCES

1. US Food & Drug Administration. FDA approves new interchangeable biosimilar to Perjeta. News release. November 13, 2025. Accessed November 13, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta

2. McGovern G. Understanding Biologics and Biosimilars Amid an Evolving Treatment Landscape. Pharmacy Times. June 12, 2025. Accessed November 13, 2025. https://www.pharmacytimes.com/view/understanding-biologics-and-biosimilars-amid-an-evolving-treatment-landscape

3. National Institutes of Health – National Library of Medicine. Pertuzumab (Perjeta): CADTH Reimbursement Review: Therapeutic area: Early-stage breast cancer [Internet]. Accessed November 13, 2025. https://www.ncbi.nlm.nih.gov/books/NBK599018/

4. Gerlach A. Neoadjuvant Chemotherapy Improves Survival in HER2-Positive Breast Cancer. Pharmacy Times. August 20, 2025. Accessed November 13, 2025. https://www.pharmacytimes.com/view/neoadjuvant-chemotherapy-improves-survival-in-her2-positive-breast-cancer