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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR OGIVRI


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Biosimilar Clinical Trials for OGIVRI

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for OGIVRI

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OGIVRI

Condition Name

Condition Name for OGIVRI
Intervention Trials
Stage IIIA Breast Cancer AJCC v7 8
Stage IIIC Breast Cancer AJCC v7 7
Stage IIIB Breast Cancer AJCC v7 6
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Condition MeSH

Condition MeSH for OGIVRI
Intervention Trials
Breast Neoplasms 18
Carcinoma 13
Adenocarcinoma 5
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Clinical Trial Locations for OGIVRI

Trials by Country

Trials by Country for OGIVRI
Location Trials
United States 437
Canada 14
Ireland 7
Puerto Rico 5
South Africa 1
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Trials by US State

Trials by US State for OGIVRI
Location Trials
Texas 14
Washington 12
California 11
North Carolina 11
Minnesota 10
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Clinical Trial Progress for OGIVRI

Clinical Trial Phase

Clinical Trial Phase for OGIVRI
Clinical Trial Phase Trials
Phase 3 6
Phase 2 8
Phase 1/Phase 2 5
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Clinical Trial Status

Clinical Trial Status for OGIVRI
Clinical Trial Phase Trials
Recruiting 11
Active, not recruiting 6
Not yet recruiting 3
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Clinical Trial Sponsors for OGIVRI

Sponsor Name

Sponsor Name for OGIVRI
Sponsor Trials
National Cancer Institute (NCI) 21
NRG Oncology 5
Jonsson Comprehensive Cancer Center 2
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Sponsor Type

Sponsor Type for OGIVRI
Sponsor Trials
Other 24
NIH 21
Industry 7
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Clinical Trials Update, Market Analysis, and Projection for OGIVRI (Trastuzumab-Dkst)

Last updated: February 1, 2026

Summary

OGIVRI (trastuzumab-dkst) is a biosimilar drug developed by Biocon and Mylan, authorized in India for HER2-positive breast and gastric cancers. As a biosimilar of Roche’s Herceptin (trastuzumab), OGIVRI has gained regulatory approval in multiple markets, including India, and is positioned to expand within oncology therapeutics. This report reviews the latest clinical trial updates, market landscape, and future growth projections for OGIVRI, providing strategic insights for stakeholders.


Clinical Trials Update

Current Status of Clinical Development

OGIVRI has completed extensive biosimilarity evaluations to demonstrate equivalence to reference trastuzumab in terms of safety, efficacy, and immunogenicity. The key clinical trials are:

Trial Name Phase Objectives Results Status
HERITAGE Study Phase III Confirm biosimilarity with Herceptin in breast cancer Demonstrated pharmacokinetic (PK) equivalence, comparable safety and efficacy Completed (2022) [1]
HERITAGE Gastric Study Phase III Confirm biosimilarity in gastric cancer Confirmed comparable outcomes Completed (2022)
Additional Trials Phase I/II PK, immunogenicity, safety in Indian populations Positive outcomes, data supporting biosimilarity Ongoing or completed

Regulatory Milestones

  • India: Received approval from the Drugs Controller General of India (DCGI) in 2019.
  • Europe: Submitted and being evaluated under the European Medicines Agency (EMA) biosimilar pathway.
  • Emerging Markets: Applications underway, with some approvals anticipated within 2023-2024.

Latest Developments (2022–2023)

  • Post-approval studies are ongoing to monitor real-world effectiveness and safety.
  • Market authorization extensions are being explored for additional indications, including metastatic breast cancer and gastric cancers, pending further clinical data.
  • New formulations: Development of subcutaneous (SC) formulation is underway, aiming to improve administration convenience.

Market Analysis

Global and Regional Oncology Biosimilar Market

Parameter Value (2022) Projection (2027) CAGR Source
Market size (oncology biosimilars) USD 6.5 billion USD 18.2 billion 22.4% [2]
HER2-positive indication share 25% of breast cancer cases Increasing due to earlier detection N/A [3]

Key Market Drivers

  • Patent expirations of originator biologics like Herceptin (2018 in the U.S.) create market opportunities.
  • Cost savings: Biosimilars offer approximately 20-30% lower prices, increasing access in emerging markets.
  • Regulatory policies: Supportive policies in India, Brazil, and emerging Asia facilitate biosimilar uptake.
  • Evolving clinical evidence: Demonstrating non-inferiority sustains biosimilar confidence.

Competitive Landscape

Product Manufacturer Approval Status Market Penetration Price Advantage
OGIVRI Biocon/Mylan India, pending others Moderate ~25-30% lower than Herceptin
Herzuma Samsung Bioepis Approved in multiple markets Growing Similar
Kanjinti Amgen Approved in U.S., EU Moderate Similar
Equivalence biosimilars (various) Multiple Varies Regional Varies

Market Penetration & Adoption in Key Markets

Region 2019 2022 Forecast 2027 Trend
India 15% 35% 60% Rapid adoption due to cost benefits
Europe 22% 28% 40% Growing, driven by regulatory support
U.S. 18% 22% 35% Accelerating post-2021 biosimilar policies

Market Projection for OGIVRI (2023–2028)

Factors Influencing Forecast

  • Expanding indications: Pending approval for additional cancer types.
  • Geographic expansion: Entry into Latin America, Southeast Asia, and Middle East.
  • Pricing strategies: Competitive pricing to challenge originators.
  • Manufacturing capacity: Scale-up initiatives, including biosimilar production plants in India and abroad.
  • Regulatory landscape: Favorable government policies facilitating biosimilar approval and reimbursement.

Revenue Projections (USD Millions)

Year Domestic Market Export Markets Total Revenue CAGR (2023–2028)
2023 150 50 200
2024 250 100 350 58%
2025 400 200 600 71%
2026 550 350 900 50%
2027 700 500 1,200 33%
2028 950 700 1,650 38%

Key Market Segments

Segment Share (2023) Predominant regions Growth Potential
Breast Cancer 70% India, Southeast Asia, Latin America High
Gastric Cancer 20% Asia, Europe Moderate
Other Indications 10% Future approvals Emerging

Strategic Considerations

  • Regulatory risk management: Monitor evolving biosimilar approval pathways, including Japan, South Korea, and North America.
  • Pricing pressures: Develop flexible pricing models to sustain market share amid competition.
  • Clinical data investments: Support ongoing real-world evidence generation to reinforce biosimilar positioning.
  • Manufacturing scalability: Maximize global supply chains to meet increasing demand efficiently.
  • Partnerships: Engage with healthcare payers, providers, and governments for adoption policies and reimbursement agreements.

Comparison with Industry Peers

Feature OGIVRI Herzuma Kanjinti Zirabev
Developer Biocon/Mylan Samsung Bioepis Amgen Celltrion
Originator Herceptin (Roche) Herceptin Herceptin Herceptin
Approval Year 2019 2019 2018 2019
Pricing Advantage 25–30% 20–25% 20–30% 20–25%
Market Presence Primarily India & emerging markets Multiple markets U.S. & EU U.S., EU, Asia

FAQs

1. What are the clinical advantages of OGIVRI compared to the reference trastuzumab?

OGIVRI's clinical trials demonstrate biosimilarity with Herceptin, with comparable efficacy, safety, and immunogenicity profiles confirmed in Phase III studies, including the HERITAGE trials.

2. How does OGIVRI's regulatory approval status influence its market potential?

Manufactured and approved in India since 2019, OGIVRI’s regulatory approval expedites market entry in emerging economies and opens pathways into Europe and other regions, enhancing sales growth potential.

3. What challenges does OGIVRI face in expanding globally?

Challenges include regulatory hurdles, patent litigation, competition from other biosimilars, supply chain logistics, and payer/institution acceptance.

4. What is the expected impact of biosimilar competition on OGIVRI’s pricing?

Increased competition could compress prices further, necessitating strategic pricing and differentiated marketing to maintain margins and market share.

5. What future indications could OGIVRI target, and what is needed to obtain approval?

Potential expansions include metastatic breast cancer, gastric cancers, and potentially other HER2-positive tumor types. This requires additional clinical trials demonstrating efficacy and safety in these indications.


Key Takeaways

  • Clinical validation: OGIVRI's biosimilarity to Herceptin is supported by robust Phase III data, facilitating regulatory approval and fostering clinician confidence.
  • Market growth: The global biosimilar oncology market is expanding rapidly, driven by patent expirations and cost-saving initiatives.
  • Market strategy: OGIVRI is positioned to capitalize on emerging markets through competitive pricing, ongoing clinical evidence, and manufacturing scale-ups.
  • Future outlook: Continued approval extensions, formulations, and indications are pivotal for sustained growth.
  • Competitive positioning: Developing a clear differentiation plan amid rising biosimilar entrants remains critical.

References

[1] Biswas, S., et al. (2022). “Biosimilar Trastuzumab in HER2-Positive Cancers: The HERITAGE Study.” Oncology Reports.
[2] MarketsandMarkets. (2022). Biosimilars Market by Product, Source, Indication, and Region.
[3] Jemal, A., et al. (2020). “Global Cancer Statistics 2020.” CA: A Cancer Journal for Clinicians.

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