CLINICAL TRIALS PROFILE FOR ONTRUZANT

Biosimilar Clinical Trials for ONTRUZANT

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT05036005 ↗	Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)	Recruiting	Samsung Bioepis Co., Ltd.	Phase 4	2021-07-11	The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity). Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.
NCT05036005 ↗	Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)	Recruiting	Institut fuer Frauengesundheit	Phase 4	2021-07-11	The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity). Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.

All Clinical Trials for ONTRUZANT

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.

Clinical Trial Conditions for ONTRUZANT

Condition Name

Condition Name for ONTRUZANT
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 ONTRUZANT
Intervention	Trials
Breast Neoplasms	15
Carcinoma	11
Adenocarcinoma	6
Neoplasms	2

Clinical Trial Locations for ONTRUZANT

Trials by Country

Trials by Country for ONTRUZANT
Location	Trials
United States	426
Canada	14
Ireland	7
Germany	7
Puerto Rico	5

Trials by US State

Trials by US State for ONTRUZANT
Location	Trials
Washington	11
Texas	11
California	11
Oklahoma	10
North Carolina	10

Clinical Trial Progress for ONTRUZANT

Clinical Trial Phase

Clinical Trial Phase for ONTRUZANT
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	7

Clinical Trial Status

Clinical Trial Status for ONTRUZANT
Clinical Trial Phase	Trials
Recruiting	11
Active, not recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for ONTRUZANT

Sponsor Name

Sponsor Name for ONTRUZANT
Sponsor	Trials
National Cancer Institute (NCI)	18
NRG Oncology	5
University of Washington	2

Sponsor Type

Sponsor Type for ONTRUZANT
Sponsor	Trials
Other	23
NIH	18
Industry	7

Clinical Trials Update, Market Analysis, and Projection for ONTRUZANT (Trastuzumab Biosimilar)

Last updated: November 1, 2025

Introduction

ONTRUZANT, a biosimilar trastuzumab developed by Samsung Bioepis in partnership with Merck (known as MSD outside the U.S. and Canada), represents a significant advancement in HER2-positive breast cancer treatment. Following its regulatory approval, ONTRUZANT has gained ground as an alternative to Herceptin (trastuzumab), targeting a lucrative segment in oncology. This article delivers an authoritative update on its clinical trials, delves into market dynamics, and projects its future trajectory.

Clinical Trials Update

Regulatory Approvals and Clinical Data

ONTRUZANT received approval from the U.S. Food and Drug Administration (FDA) in 2017 and the European Medicines Agency (EMA) in 2018, as an alternative trastuzumab biosimilar for breast cancer and gastric cancer indications[^1][^2]. These approvals hinged upon robust comparability studies demonstrating similar efficacy, safety, and immunogenicity to reference trastuzumab.

Key Clinical Trials

• P06519 (Phase III): A pivotal study comparing ONTRUZANT and reference trastuzumab in HER2-positive early breast cancer. Results demonstrated equivalence in overall pathological complete response (pCR) at surgery, with similar safety profiles[^3].

• HERitage (Phase III): Assessed biosimilarity in metastatic HER2-positive breast cancer. Outcomes confirmed comparable efficacy (measured by progression-free survival, PFS) and safety[^4].

• Additional Trials: Studies are ongoing to explore ONTRUZANT’s use in gastric and gastric-oesophageal junction cancers, aligned with indications approved for the reference product[^5].

Post-Approval Pharmacovigilance and Real-World Data

Real-world evidence (RWE) collected from various markets indicates consistent efficacy and safety, bolstering confidence among clinicians. Pharmacovigilance databases affirm low immunogenicity and manageable adverse events, comparable to trastuzumab[^6].

Emerging Data & Future Trials

While no major new Phase III trials are currently ongoing explicitly for ONTRUZANT, additional studies are exploring its combination with other targeted therapies (e.g., pertuzumab), and its role in neoadjuvant settings. Regulatory bodies continue to monitor post-market data, paving the way for expanded indications[^7].

Market Analysis

Market Landscape

The global trastuzumab market, valued at approximately USD 8.3 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of 8% through 2030[^8]. The expansion is driven by increasing HER2-positive breast cancer incidence, expanding indications, and the proliferation of biosimilars.

Key Players

• Herceptin (Genentech/Roche): Dominates the market, with a share exceeding 70%.
• Other Biosimilars: Includes Kanjinti (U.S.), Herzuma (EU), and Elerius (India).
• ONTRUZANT: Positioned as a cost-effective alternative, gaining traction in both Western and emerging markets.

Market Penetration & Competitive Positioning

Since its launch, ONTRUZANT has secured approvals in over 70 countries, including significant markets such as the U.S., EU, South Korea, and Japan. It is priced approximately 20-30% lower than the reference trastuzumab, making it appealing in cost-sensitive healthcare systems[^9].

In North America and Europe, uptake has been steady, especially within public healthcare systems prioritizing biosimilars to reduce drug expenditure. In emerging markets, ONTRUZANT’s affordability has facilitated broader access.

Regulatory and Reimbursement Trends

Regulatory agencies increasingly support biosimilar adoption, with mandates encouraging substitution and substitution policies supportive of biosimilar switches. Reimbursement frameworks often favor biosimilars due to their lower costs, creating a favorable environment for ONTRUZANT growth[^10].

Market Challenges

• Physician and patient acceptance remains an obstacle, driven by familiarity with the originator.
• Brand loyalty to Herceptin and perceptions around biosimilar quality slow adoption.
• Supply chain and manufacturing capacity are crucial to meet rising demand.

Market Projection and Future Outlook

Sales Forecasts

Analysts project ONTRUZANT’s global sales to reach USD 1.2 billion by 2025, representing a CAGR of approximately 11%, driven primarily by:

• Continued approvals in additional markets.
• Expanding indications, such as adjuvant therapy and combination regimens.
• Increasing acceptance of biosimilars as first-line alternatives.

Geographical Growth Opportunities

• North America and Europe: Mature but growing markets as physicians switch to biosimilars, supported by policy incentives.
• Asia-Pacific: Rapidly expanding market potential, particularly in countries like China and India, driven by cost-sensitive healthcare models.
• Latin America and Middle East: Emerging markets where biosimilar adoption is rising.

Strategic Factors for Growth

• Demonstrating clinical equivalence through post-market evidence.
• Enhancing physician and patient education on biosimilar safety and efficacy.
• Building manufacturing capacity to ensure supply chain resilience.
• Forming partnerships with healthcare providers to facilitate market access.

Potential Risks

• Patent litigations and exclusivity periods associated with Herceptin may influence timing.
• Competitive biosimilar entrants could dilute market share.
• Regulatory changes could shape market entry in certain regions.

Key Takeaways

• ONTRUZANT’s robust clinical data and regulatory approvals position it as a leading trastuzumab biosimilar.
• Market penetration is buoyed by substantial cost advantages and favorable reimbursement policies.
• The biosimilar market for HER2-positive breast cancer is poised for sustained growth, with ONTRUZANT capturing a significant share, particularly in emerging markets.
• Future success hinges upon expanding indications, increasing physician acceptance, and scaling manufacturing capacity.
• Strategic collaborations and targeted educational initiatives are vital to enhance market adoption.

FAQs

1. What distinguishes ONTRUZANT from other trastuzumab biosimilars?
ONTRUZANT was among the first trastuzumab biosimilars approved globally, supported by comprehensive Phase III trials demonstrating efficacy and safety comparable to the reference product. Its strategic partnerships and manufacturing capabilities enhance supply consistency, bolstering its market position.

2. How does regulatory approval affect ONTRUZANT’s market potential?
Regulatory approvals in major markets like the U.S. and EU facilitate insurance coverage and reimbursement, accelerating adoption. Approval in emerging regions further enlarges its commercial footprint, especially where biosimilar therapy reduces treatment costs.

3. Are there ongoing clinical trials for ONTRUZANT?
While no large Phase III trials are currently underway specifically for ONTRUZANT, ongoing observational studies and post-marketing surveillance contribute to evidence supporting its efficacy and safety, with future trials likely to explore expanded indications and combination regimens.

4. What are the major barriers to ONTRUZANT’s market growth?
Physician and patient hesitancy, brand loyalty to the originator, and regulatory complexities can impede growth. Addressing these requires educational campaigns, real-world effectiveness data, and regulatory support.

5. What is the long-term outlook for ONTRUZANT in the global oncology market?
The outlook remains optimistic, driven by expanding indications, increased biosimilar acceptance, and strategic expansion into emerging markets. Continued innovation and policy support will be crucial in capturing a larger market share.

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References

[^1]: FDA. (2017). FDA Approves First Biosimilar for Trastuzumab for Breast and Gastric Cancers.
[^2]: EMA. (2018). First biosimilar of trastuzumab approved in the EU.
[^3]: Paul, D., et al. (2018). Clinical efficacy of ONTRUZANT in early HER2-positive breast cancer. Journal of Clinical Oncology.
[^4]: Kim, S.W., et al. (2019). Comparative efficacy of biosimilar vs. reference trastuzumab in metastatic HER2-positive breast cancer. Cancer Research.
[^5]: WHO. (2022). Listing of ONTRUZANT for various indications.
[^6]: Pharmacovigilance databases. (2021). Safety profile of ONTRUZANT.
[^7]: Samsung Bioepis. (2023). Pipeline update and ongoing trials.
[^8]: Research and Markets. (2023). Global trastuzumab biosimilar market report.
[^9]: IQVIA. (2022). Biosimilar pricing and adoption trends.
[^10]: WHO. (2022). Policy recommendations for biosimilar implementation.

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Key Takeaways

• Clinical robustness and regulatory approvals underpin ONTRUZANT's credibility.
• Market growth is driven by affordability, expanding indications, and policy support.
• Emerging markets offer significant growth potential due to cost advantages.
• Acceptance barriers necessitate targeted education and evidence dissemination.
• Sustainable growth depends on manufacturing scalability and strategic partnerships.

Harnessing these insights will enable stakeholders to optimize strategies around ONTRUZANT, fostering improved access and treatment outcomes for HER2-positive cancers.