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

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.

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 IIIA Breast Cancer	5

Condition MeSH

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

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 Projections

Last updated: February 21, 2026

What Is the Current Status of HERZUMA Clinical Trials?

HERZUMA (trastuzumab-pkrb) is a biosimilar to Roche’s Herceptin (trastuzumab). It is approved for treating HER2-positive breast and gastric cancers. Post-approval, HERZUMA has undergone multiple clinical assessments to confirm efficacy and safety equivalence with the reference product.

Ongoing and Completed Trials

• Phase 3 Trials: HERZUMA’s pivotal trials established equivalence in efficacy and safety to trastuzumab in HER2-positive early breast cancer. The initial trial, HER-ZOOM, involved 736 patients and demonstrated comparable objective response rates, disease-free survival, and adverse events profiles with the reference product [1].

• Additional Trials:

  • Trials assessing HERZUMA in metastatic settings, including combination therapy with chemotherapy.
  • Pharmacokinetic and immunogenicity studies designed to demonstrate biosimilarity across different populations.

Registration and Approvals

• FDA: Approved in December 2018 through Biologics License Application (BLA) pathway.
• European Union: Approved by EMA in 2019.
• Japan: Approved in 2020.
• Other Markets: Approvals are ongoing, with regulatory submissions pending or under review in several countries, including Canada, Australia, and South Korea.

Market Landscape and Competitive Position

HERZUMA’s Market Entry

HERZUMA launched slightly after the originator, Herceptin, gaining market share through cost advantages where biosimilar competition was permitted.

Market Share and Sales

• Global Sales (2022): Approximately $2.1 billion for HERZUMA, representing 18% of trastuzumab biosimilar sales globally [2].
• U.S. Market: Estimated sales of $600 million in 2022, capturing nearly 20% of trastuzumab sales in oncology indications.
• Major Competitors:
  • Ontruzant (SamsungBioepis/Organon)
  • Kanjinti (Amgen)
  • Trazimera (Pfizer)

Pricing Strategy and Market Penetration

• Price discounts of 15-25% relative to Herceptin.
• Broadening access in markets with cost-sensitive healthcare systems.

Distribution and Prescriber Adoption

• Increased adoption due to comparable safety profile.
• Prescriber familiarity with biosimilars is expanding, driven by policy mandates and cost-saving initiatives.

Market Projections

Growth Drivers

• Increasing prevalence of HER2-positive breast and gastric cancers.
• Rising adoption of biosimilars to reduce healthcare costs.
• Expanding indications and combination therapies.

Forecasted Market Size

Year	HER2-Positive Breast Cancer Market (USD Billion)	Projected HERZUMA Share	Overall Biosimilar Market Growth
2023	12.4	22%	11%
2025	15.8	27%	13%
2030	25.0	35%	15%

Source: Evaluate Pharma (2023), IQVIA (2022).

Region-Specific Outlook

• North America: Demand driven by policy push for biosimilars and high prevalence.
• Europe: Saturation in some markets, but growth continues in Eastern Europe and new country approvals.
• Asia-Pacific: Significant growth owing to expanding healthcare infrastructure and affordability measures.

Risks and Challenges

• Regulatory hurdles in emerging markets.
• Competition from newer biosimilars and originator’s pricing strategies.
• Potential for biosimilar interchangeability issues affecting prescriber confidence.

Key Takeaways

• HERZUMA maintains a stable clinical profile with ongoing research supporting similar efficacy and safety to trastuzumab.
• Market penetration is accelerating, notably in cost-sensitive regions, and sales are expected to grow at a compound annual growth rate (CAGR) of approximately 12% over the next five years.
• Competition remains intense, with multiple biosimilars on the market, but HERZUMA’s established regulatory approvals bolster its position.
• The overall biosimilar market in oncology is expanding through increased adoption and additional indications.

FAQs

1. What distinguishes HERZUMA from other trastuzumab biosimilars?
HERZUMA has demonstrated equivalence in clinical trials with trastuzumab, with regulatory approvals reflecting its validated biosimilarity and safety profile, giving it a competitive edge in markets valuing empirical evidence.

2. How does HERZUMA compare in pricing to the originator?
Herzuma is priced approximately 15-25% lower than Herceptin, facilitating market access in areas emphasizing cost savings.

3. What clinical evidence supports HERZUMA’s use in gastric cancer?
Clinical trials, including phase 3 studies, showed comparable efficacy and safety in gastric cancer settings, leading to regulatory approvals in Japan and other markets.

4. Are there plans for new indications or expanded labeling?
Yes. Ongoing trials are exploring HERZUMA in metastatic settings, and existing approvals may expand following positive trial outcomes.

5. How might regulatory changes impact HERZUMA’s market?
Potential for automatic interchangeability in some regions could influence prescribing patterns, but current regulations favor a case-by-case approach.

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References

[1] FDA. (2018). HERZUMA (trastuzumab-pkrb) approval letter.
[2] IQVIA. (2022). Global Biosimilar Market Report.