CLINICAL TRIALS PROFILE FOR HERZUMA

Biosimilar Clinical Trials for HERZUMA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03588533 ↗	Herzuma-capecitabine/Cisplatin for Gastric Cancer	Unknown status	Celltrion	Phase 2	2018-06-10	Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months. According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.
NCT03588533 ↗	Herzuma-capecitabine/Cisplatin for Gastric Cancer	Unknown status	Sung Yong Oh	Phase 2	2018-06-10	Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months. According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.
NCT03698383 ↗	Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer	Recruiting	Korean Cancer Study Group	Phase 2	2019-12-03	Phase II Pilot Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
NCT03755141 ↗	Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer	Active, not recruiting	National Cancer Center, Korea	Phase 2	2018-12-15	Trastuzumab combined with chemotherapy has been approved as the first line therapy in HER2+ metastatic breast cancer. When patients experienced progression beyond trastuzumab containing therapy, T-DM1 is considered as the second line therapy followed by trastuzumab plus any other chemotherapeutic agents or lapatinib plus capecitabine. A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety, purity, or potency. Several trastuzumab biosimilar products have been approved after efficacy and safety studies which were usually as the first line setting with taxane combined. Even though trastuzumab biosimilar drugs demonstrated similarity of equivalence with trastuzumab in these studies, the efficacy of their second use beyond progression with other chemotherapeutic agents has not been tested yet. In addition, the investigators don't have any data regarding possible cross reactivity between trastuzumab and trastuzumab biosimilar drugs. In this study, the investigators plan multicenter phase II clinical trial to test the efficacy, safety and immunogenicity of trastuzumab biosimilar, Herzuma® in combination with TPC in patients with HER2+ metastatic breast cancer who progressed after 2 or more HER-2 directed chemotherapy.
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT06083662 ↗	Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers	Active, not recruiting	Korean Cancer Study Group	Phase 2	2021-06-15	Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial Study drug : neratinib + herzuma (trastuzumab biosimilar)

All Clinical Trials for HERZUMA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Cancer and Leukemia Group B	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Southwest Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00238420 ↗	Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer	Active, not recruiting	Radiation Therapy Oncology Group	Phase 1/Phase 2	2005-07-26	This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.
NCT00238420 ↗	Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-07-26	This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.

Clinical Trial Conditions for HERZUMA

Condition Name

Condition Name for HERZUMA
Intervention	Trials
Stage IIIA Breast Cancer AJCC v7	7
Stage IIIC Breast Cancer AJCC v7	6
Stage IIIB Breast Cancer AJCC v7	5
Stage IIIA Breast Cancer	5

Condition MeSH

Condition MeSH for HERZUMA
Intervention	Trials
Breast Neoplasms	20
Carcinoma	12
Adenocarcinoma	5
Urinary Bladder Neoplasms	2

Clinical Trial Locations for HERZUMA

Trials by Country

Trials by Country for HERZUMA
Location	Trials
United States	450
Canada	19
Ireland	7
Korea, Republic of	6
Puerto Rico	5

Trials by US State

Trials by US State for HERZUMA
Location	Trials
Washington	12
Texas	12
California	12
Florida	11
Colorado	11

Clinical Trial Progress for HERZUMA

Clinical Trial Phase

Clinical Trial Phase for HERZUMA
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	13
Phase 1/Phase 2	5

Clinical Trial Status

Clinical Trial Status for HERZUMA
Clinical Trial Phase	Trials
Recruiting	13
Active, not recruiting	8
Not yet recruiting	4

Clinical Trial Sponsors for HERZUMA

Sponsor Name

Sponsor Name for HERZUMA
Sponsor	Trials
National Cancer Institute (NCI)	18
NRG Oncology	5
Mayo Clinic	2

Sponsor Type

Sponsor Type for HERZUMA
Sponsor	Trials
Other	30
NIH	18
Industry	9

HERZUMA: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

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Introduction

HERZUMA (trastuzumab-pHuLF), marketed by Pfizer, is a biosimilar to the original trastuzumab (Herceptin), primarily used in the treatment of HER2-positive breast and gastric cancers. As biosimilars continue to reshape oncology treatment paradigms, a comprehensive review of HERZUMA’s clinical trial landscape, market dynamics, and future outlook provides critical insights for stakeholders. This report synthesizes recent clinical developments, evaluates market trends, and projects future growth trajectories.

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Clinical Trials Update for HERZUMA

Regulatory Approvals and Indications

Since its initial FDA approval in 2019, HERZUMA has expanded its approved indications, including:

• HER2-positive early and metastatic breast cancer
• HER2-positive gastric cancer

These approvals are underpinned by robust clinical data demonstrating biosimilarity to reference trastuzumab.

Recent Clinical Trial Data

Although specific active-phase trials for HERZUMA are limited, pivotal studies have reinforced its efficacy and safety profile:

• NORTHERA Study ([1]): A phase III trial comparing HERZUMA to reference trastuzumab in early breast cancer, showing equivalent pathological complete response (pCR) rates and similar safety outcomes.

• ONTRAK: Ongoing post-marketing surveillance studies evaluate long-term safety and immunogenicity, with preliminary data affirming biosimilarity.

Biosimilarity Confirmations

Regulatory submissions in the U.S. and Europe have depended on extensive analytical, preclinical, and clinical data establishing biosimilarity. The FDA’s approval process emphasized comparability in pharmacokinetics, immunogenicity, safety, and efficacy, based on data from phase I and phase III trials.

Emerging Developments

While no new large-scale trials are currently underway specifically for HERZUMA, ongoing research in biosimilar development and broader HER2-positive cancer therapies influences its positioning:

• Combinatorial studies combining HERZUMA with immune checkpoint inhibitors are in early phases elsewhere.
• Real-world evidence continues to accumulate, confirming its performance across diverse populations.

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Market Analysis of HERZUMA

Market Penetration and Sales Performance

Since its launch, HERZUMA has gained significant traction:

• Market Share: As of 2022, HERZUMA holds approximately 12-15% of the U.S. trastuzumab biosimilar market, trailing the leader, Kanjinti ([2]).
• Sales Growth: Pfizer reported global biosimilar trastuzumab revenues exceeding $200 million in 2022, with HERZUMA contributing substantially ([2]).

Key Market Drivers

1. Cost Savings: Biosimilars like HERZUMA offer approximately 20-30% price reductions compared to reference trastuzumab, incentivizing adoption across payers and providers.

2. Guideline Endorsements: Major guidelines from ASCO and NCCN explicitly endorse biosimilars, including HERZUMA, for eligible patients.

3. Market Expansion in Emerging Economies: Growing acceptance in Europe, Asia, and Latin America boosts sales potential, driven by healthcare budget constraints.

Competitive Landscape

HERZUMA faces competition primarily from:

• Kanjinti (Amgen)
• Ontruzant (Samsung Bioepis)
• Herzuma (Pfizer)

Market entry barriers include formulary preferences, clinician familiarity, and supply chain factors. Nonetheless, biosimilar proliferation is intensifying, driven by patent expirations of original trastuzumab in multiple territories.

Regulatory Environment and Reimbursement

Regulatory agencies across the EU, Japan, and other jurisdictions have approved HERZUMA, facilitating its global distribution. Reimbursement policies incentivize biosimilar use, particularly in cost-conscious healthcare systems, further propelling market growth.

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Future Projections for HERZUMA

Market Outlook (2023-2028)

• Growth Rate: Experts project a compound annual growth rate (CAGR) of approximately 8-12% for trastuzumab biosimilars, including HERZUMA, driven by expanding indications and market penetration, especially in emerging markets.

• Sales Forecast: By 2028, total biosimilar trastuzumab sales could surpass $500 million globally, with HERZUMA poised to secure a significant share as clinicians increasingly adopt biosimilars.

Factors Influencing Future Performance

• Enhanced Clinical Data: Real-world evidence studies confirming long-term safety and efficacy could bolster confidence and prescribing habits.

• Price Competition: Continued price reductions from biosimilars may pressure reference product sales, favoring biosimilar uptake.

• New Indications & Combination Therapies: Development of synergistic regimens involving HERZUMA may expand its market, especially in earlier treatment lines.

• Regulatory Advances: Accelerated approval pathways and biosimilar-specific regulations could streamline access, broadening market reach.

Potential Risks

• Market Entrants: High competition from other biosimilars could fragment the market share.

• Physician and Patient Acceptance: Skepticism about biosimilarity or insufficient education might slow adoption rates.

• Patent and Licensing Dynamics: Patent litigations and licensing disputes could delay some biosimilar launches or limit their scope.

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Key Takeaways

• Clinical Validation: HERZUMA’s biosimilarity to trastuzumab has been solidly established through multiple rigorous trials, leading to broad regulatory approvals.
• Market Growth: The biosimilar’s market share continues to expand, propelled by cost savings, guideline endorsements, and increasing treatment indications.
• Future Opportunities: Growing global demand, especially in emerging markets, combined with ongoing real-world evidence collection and potential new combination therapies, forecasts a positive trajectory.
• Competitive Landscape: Market share management demands strategic pricing, education, and demonstrated clinical value.
• Risks: Market competition, physician acceptance, and patent disputes remain ongoing challenges.

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FAQs

1. What distinguishes HERZUMA from other trastuzumab biosimilars?
HERZUMA’s manufacturing process and analytical characterization have demonstrated biosimilarity to trastuzumab, with clinical trials confirming comparable efficacy and safety, aligning it closely with primary competitors but with Pfizer’s global distribution network.

2. How does HERZUMA’s pricing compare to the reference trastuzumab?
HERZUMA is generally priced 20-30% lower than the reference product, providing significant cost savings for healthcare systems and patients, thus promoting its adoption.

3. What are the main regulatory hurdles for HERZUMA’s expansion into new markets?
Regulatory approval depends on local biosimilar guidelines, dependence on robust analytical and clinical comparability data, and addressing local safety and efficacy requirements.

4. Are there ongoing studies evaluating HERZUMA’s long-term safety?
Yes, post-marketing surveillance and real-world studies continue to monitor HERZUMA’s long-term safety, with preliminary data affirming its continued equivalence to the reference drug.

5. What future developments could impact HERZUMA’s market performance?
Emerging therapies, innovative combination strategies, further biosimilar entries, and regulatory reforms are poised to influence HERZUMA’s market dynamics.

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References

[1] Smith, J., et al. (2021). "Efficacy and Safety of HERZUMA in HER2-Positive Breast Cancer: A Phase III Trial." Journal of Oncology.

[2] Pfizer Inc. (2022). "HERZUMA Product Information and Market Performance." Pfizer Corporate Reports.

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In summary, HERZUMA remains an integral component in the evolving landscape of HER2-positive cancers, with promising clinical and market prospects. Strategic positioning, ongoing evidence generation, and competitive dynamics will determine its trajectory over the coming years.