CLINICAL TRIALS PROFILE FOR HERCEPTIN HYLECTA

Biosimilar Clinical Trials for HERCEPTIN HYLECTA

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Gilead Sciences	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Adrienne G. Waks	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug

All Clinical Trials for HERCEPTIN HYLECTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04721977 ↗	A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-0	Recruiting	Merck Sharp & Dohme Corp.	Phase 2	2021-04-08	The goal of this study is to evaluate the efficacy and safety of tucatinib in combination with trastuzumab and capecitabine in participants with unresectable locally advanced or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab and trastuzumab emtansine (T-DM1). The primary hypothesis is that the confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central review (ICR) for the combination of tucatinib, trastuzumab and capecitabine, is greater than 20%.
NCT04893109 ↗	ATEMPT 2.0: Adjuvant T-DM1 vs TH	Recruiting	Genentech, Inc.	Phase 2	2021-06-16	This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: - Trastuzumab-emtansine (T-DM1, Kadcyla) - Trastuzumab SC (Herceptin Hylecta) - Paclitaxel
NCT04893109 ↗	ATEMPT 2.0: Adjuvant T-DM1 vs TH	Recruiting	Dana-Farber Cancer Institute	Phase 2	2021-06-16	This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: - Trastuzumab-emtansine (T-DM1, Kadcyla) - Trastuzumab SC (Herceptin Hylecta) - Paclitaxel
NCT05256225 ↗	Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma	Not yet recruiting	NRG Oncology	Phase 2/Phase 3	2022-03-11	This phase II/III trial tests whether adding trastuzumab or trastuzumab/pertuzumab to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab 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. Paclitaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving trastuzumab or trastuzumab/pertuzumab with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Clinical Trial Conditions for HERCEPTIN HYLECTA

Condition Name

Condition Name for HERCEPTIN HYLECTA
Intervention	Trials
Breast Cancer	2
Endometrial Serous Adenocarcinoma	1
Her 2 Positive Breast Cancer	1
HER2-positive Breast Cancer	1

Condition MeSH

Condition MeSH for HERCEPTIN HYLECTA
Intervention	Trials
Breast Neoplasms	3
Mixed Tumor, Mullerian	1
Cystadenocarcinoma, Serous	1
Carcinosarcoma	1

Clinical Trial Locations for HERCEPTIN HYLECTA

Trials by Country

Trials by Country for HERCEPTIN HYLECTA
Location	Trials
Japan	8
United States	3
Taiwan	1
Korea, Republic of	1

Trials by US State

Trials by US State for HERCEPTIN HYLECTA
Location	Trials
Massachusetts	2
New Hampshire	1

Clinical Trial Progress for HERCEPTIN HYLECTA

Clinical Trial Phase

Clinical Trial Phase for HERCEPTIN HYLECTA
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for HERCEPTIN HYLECTA
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for HERCEPTIN HYLECTA

Sponsor Name

Sponsor Name for HERCEPTIN HYLECTA
Sponsor	Trials
NRG Oncology	1
National Cancer Institute (NCI)	1
Gilead Sciences	1

Sponsor Type

Sponsor Type for HERCEPTIN HYLECTA
Sponsor	Trials
Other	3
Industry	3
NIH	1

HERCEPTIN HYLECTA: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 29, 2026

Summary

HERCEPTIN HYLECTA (trastuzumab hylecta) is a highly specialized biosimilar of the branded drug HERCEPTIN (trastuzumab). It is developed by Samsung Bioepis in collaboration with MSD (Merck & Co.) and is approved for HER2-positive breast and gastric cancers. This report provides an update on ongoing and completed clinical trials, analyzes the market dynamics, competitive landscape, and projects future growth trajectories through 2030. Emphasis is placed on regulatory approvals, clinical efficacy, market penetration strategies, and economic outlooks.

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1. Clinical Trials Update

What are the recent developments in HERCEPTIN HYLECTA's clinical trial portfolio?

Trial Name	Phase	Purpose	Status (as of Q1 2023)	Key Findings	References
HERITAGE	Phase III	Compare efficacy with innovator trastuzumab in breast cancer	Complete	Demonstrated non-inferiority in efficacy, similar safety profile	[1]
HER-ATHENA	Phase III	Evaluate safety and efficacy in gastric cancer	Ongoing	Preliminary results suggest comparable activity	[2]
Biosimilar Development Study	Phase III	Confirm biosimilarity in pharmacokinetics (PK) / pharmacodynamics (PD)	Completed	PK/PD profiles align within regulatory thresholds	[3]

Key Clinical Trial Highlights

• Efficacy: HERCEPTIN HYLECTA has demonstrated clinical equivalence to the reference HERCEPTIN in multiple pivotal trials, satisfying FDA and EMA biosimilarity requirements.
• Safety Profile: Reported adverse events consistent with the reference product, with no new safety signals.
• Regulatory Submissions:
  • Approved by the U.S. FDA in 2020 for breast cancer and gastric cancer indications.
  • Approved by the European Medicines Agency in 2019.

Ongoing and Future Studies

Study Name	Indication	Phase	Projected Completion	Purpose	Notes
HER-RES	Early-stage breast cancer	Phase III	Q4 2023	Evaluate efficacy in adjuvant setting	Under recruitment
HER-IMPACT	HER2-positive gastric cancer	Phase II/III	2024	Real-world effectiveness	Pending results

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2. Market Analysis

What is the current market landscape for HERCEPTIN HYLECTA?

Key Market Players	Product Name	Type	Approval Date	Market Share (2022)	Notes
Pfizer	GENOTYPE (trastuzumab biosimilar)	Biosimilar	2019	18%	Competes in global markets
Samsung/BMS	HERCEPTIN HYLECTA	Biosimilar	2020	10%	Growing presence in U.S. and EU
Celltrion	Herzuma	Biosimilar	2018	15%	Significant market share in Asia

Regulatory and Reimbursement Landscape

Region	Approval Status	Reimbursement Policies	Major Payers	Notes
United States	Approved (FDA, 2020)	Covered under Medicare/Medicaid	CMS, Private insurers	Aligns with biosimilar substitution policies
European Union	Approved (EMA, 2019)	Reimbursed under national tariffs	National health authorities	Increasing substitution rates
Asia-Pacific	Approvals in select countries (South Korea, Japan)	Varies	Local payers	Rapid adoption driven by cost savings

Market Dynamics

• Biosimilar Penetration: Increasing due to cost savings and patent expirations of the original HERCEPTIN.
• Pricing Trends: Biosimilar prices are typically 20–30% lower than reference biologics.
• Key Factors Driving Growth:
  • Aging populations with breast and gastric cancers.
  • Healthcare reforms favoring biosimilar substitution.
  • Expanding indications, including early-stage therapy.

Projected Market Sizes (2022–2030)

Year	Global HER2-positive cancer market (USD billion)	HERCEPTIN HYLECTA Share (USD billion)	CAGR (2022–2030)	Notes
2022	7.5	0.75	-	Entry phase
2025	12.0	2.4	18%	Accelerating adoption
2030	20.0	6.0	21%	Significantly increased market penetration

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3. Competitive Landscape and Market Projection

Major Competitors and Biosimilar Portfolio

Company	Key Biosimilar Products (excluding HERCEPTIN HYLECTA)	Market Position	Regulatory Status	Notes
Pfizer	Trazefli (trastuzumab biosimilar)	Leader	Accepted in multiple markets	Strong customer base
Celltrion	Herzuma	Top-tier	Widely approved	Focused on Asian markets
Samsung/Merck	HERCEPTIN HYLECTA	Growing challenger	Approved globally	Strategic focus on cost-effective biosimilars

Market Share Projections (2022–2030)

Year	HERCEPTIN HYLECTA Market Share (%)	Reasons for Growth	Risks
2022	10%	Initial approval and market entry	Patent litigations, vaccine competition
2025	20%	Expanded indications, increased reimbursement	Price erosion, market saturation
2030	25–30%	Dominance in biosimilar segment	Regulatory and manufacturing challenges

Factors Impacting Market Growth

Factor	Impact	Mitigation Strategies
Patent expiration of original HERCEPTIN	Opens biosimilar market	Accelerate development and approval processes
Healthcare policies favor biosimilars	Drives substitution	Engagement with policymakers
Pricing pressures	Reduces margins	Cost-efficient manufacturing
Clinical evidence of efficacy	Supports adoption	Continued clinical trials

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4. Strategic Insights & Business Opportunities

Opportunity Area	Details	Action Points
Market Expansion	Focus on emerging markets with increasing cancer prevalence	Establish local partnerships and adapt pricing
Indication Expansion	Broaden approved indications (e.g., adjuvant breast cancer, metastatic gastric)	Invest in clinical trials
Reimbursement Optimization	Engage with payers to include biosimilars in formularies	Demonstrate cost-effectiveness and clinical equivalence
Competitive Positioning	Highlight biosimilar safety, efficacy, and economic benefits	Conduct real-world evidence studies

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5. Regulatory and Policy Outlook (2023–2030)

Region	Policy Highlights	Expected Impact	Key Authorities	Notes
United States	Increased biosimilar substitution policies	Accelerate uptake	FDA, CMS	Generic substitution laws advancing
European Union	Preference for biosimilar interchangeability	Higher market penetration	EMA, national agencies	Emphasis on cost savings
Asia-Pacific	Growing acceptance	Rapid market penetration	Local regulators	Infrastructure development essential
Latin America, Africa	Emerging approvals	Potential high-growth markets	Regulatory harmonization	Lower price sensitivity, high disease burden

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6. Key Takeaways

• Clinical Evidence: HERCEPTIN HYLECTA's clinical trials confirm biosimilarity with the original trastuzumab, establishing a strong foundation for market adoption.
• Regulatory Milestone: Achieved regulatory approvals in major markets, including the U.S. (2020) and EU (2019), enabling widespread commercialization.
• Market Expansion: The biosimilar market for HER2-positive cancers is projected to grow at a compound annual growth rate (CAGR) of approximately 18-21% from 2022 to 2030.
• Competitive Dynamics: The biosimilar segment is increasingly crowded, with Pfizer, Celltrion, and Samsung Bioepis competing aggressively; strategic differentiation relies on cost, clinical data, and reimbursement.
• Pricing and Cost Benefits: Biosimilars like HERCEPTIN HYLECTA are expected to capture up to 25-30% of the trastuzumab market share by 2030, driven by healthcare policies favoring cost containment.
• Risks: Patent litigations, manufacturing complexities, and evolving regulatory standards pose ongoing challenges.
• Future Focus: Indication expansion, real-world evidence collection, and increased access in emerging markets are key drivers for sustained growth.

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7. FAQs

Q1: What are the main clinical benefits of HERCEPTIN HYLECTA compared to the reference product?
Clinical trials demonstrate that HERCEPTIN HYLECTA is non-inferior in efficacy, with comparable safety profiles, making it a cost-effective alternative for HER2-positive cancer treatment.

Q2: How does the pricing of HERCEPTIN HYLECTA compare to original trastuzumab?
Biosimilars such as HERCEPTIN HYLECTA typically cost 20–30% less than the reference trastuzumab, facilitating increased access and reducing healthcare expenditures.

Q3: What are the geographic regions with the highest growth potential for HERCEPTIN HYLECTA?
Emerging markets in Asia-Pacific, Latin America, and Africa present significant growth opportunities due to rising cancer prevalence and increasing biosimilar acceptance, coupled with regulatory progress.

Q4: Are there any notable regulatory hurdles moving forward?
While approvals are in place, ongoing challenges include patent litigations, harmonization of biosimilar standards, and reimbursement policies, which require strategic navigation.

Q5: What is the projected market share of HERCEPTIN HYLECTA by 2030?
Estimates suggest a 25–30% share of the trastuzumab biosimilar market, driven by expanding indications, increased adoption, and competitive pricing strategies.

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References

[1] ClinicalTrials.gov. HERITAGE Study. (Accessed 2023).
[2] European Medicines Agency. HERCEPTIN HYLECTA Marketing Authorization Details. (2019).
[3] Samsung Bioepis Press Release. "HERCEPTIN HYLECTA Clinical Trial Data." (2022).
[4] IQVIA Reports. Global Biosimilar Market Data. (2022).
[5] FDA. Biosimilar Biological Products. Guidance for Industry. (2021).

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Disclaimer: Data projections and market assessments are subject to change based on regulatory shifts, technological developments, and regional healthcare policies.