Last updated: February 14, 2026
Overview of NDC 55513-0137
NDC 55513-0137 corresponds to Kanjinti (trastuzumab-anns), a biosimilar monoclonal antibody modeled after Herceptin (trastuzumab). Approved by the FDA in December 2018, Kanjinti is indicated for HER2-positive breast cancer and gastric cancers. Its patent expiry was targeted for 2021 or 2022, with biosimilar entry influencing the competitive landscape.
Market Landscape
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Current Market Size
The trastuzumab market was valued at approximately $2.8 billion in the US in 2022, with Herceptin accounting for around 80% of the segment. Biosimilar penetration was about 25% nationally as of 2022, driven by insurance coverage and negotiations.
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Key Competitors
Besides Kanjinti, other biosimilar trastuzumab products like Ogivri (Mylan/Biocon), Herzuma (Celltrion), and Kanjinti (Samsung Bioepis) are marketed. The original Herceptin remains dominant but faces rapid erosion with biosimilar entry anticipated to increase.
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Adoption Trends
Biosimilar acceptance in the US increased from 10% in 2020 to 25% in 2022. Growing familiarity among clinicians and payer negotiations have shaped the trajectory.
Pricing Dynamics
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Historical Pricing
The list price for Herceptin in 2022 averaged about $2,950 per 440 mg vial. Biosimilars' prices initially ranged from 15% to 30% below the originator, with discounts increasing over 2023 due to market competition.
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Current Price Estimates (2023)
Biosimilar trastuzumab (Kanjinti) prices hover around $2,200 to $2,600 per vial. Negotiated prices vary by payer and region but drive significant cost savings, with some hospitals reporting reductions of 25% to 35% compared with originator.
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Projected Price Trends (Next 2-5 Years)
- Biosimilar prices are expected to decline further, reaching 40% to 50% discounts relative to the originator by 2025.
- The entry of additional biosimilars can push prices down by an extra 10% to 20%.
- Contractual discounts and rebates may reduce net payer costs, but list prices will continue to reflect competitive pressures.
Market Penetration Forecast
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Short-term (next 1-2 years):
Biosimilar share could reach 40% as formulary coverage expands. Uptake depends on clinician familiarity and insurer incentives.
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Medium-term (3-5 years):
Biosimilar trastuzumab could dominate 70%-80% of the market volume, primarily replacing Herceptin. Price declines and broad acceptance will be key.
Regulatory and Patent Landscape
- Patent expirations and biosimilar approvals drive pricing and market evolution.
- Competition from exclusive licensing agreements and patent litigations might delay generic entry elsewhere but are less relevant for biosimilars like Kanjinti approved in the US.
Implications for Stakeholders
- Pharmaceutical companies leveraging biosimilar entry should anticipate decreasing net prices.
- Payers will benefit from reduced drug costs; providers must adjust formulary strategies accordingly.
- Manufacturers of the originator product need to innovate or improve value propositions to maintain market share.
Key Takeaways
- NDC 55513-0137 (Kanjinti) is a biosimilar trastuzumab with a significant market share expected to grow.
- Biosimilar prices are projected to decrease to 40%-50% below originator prices within 2-3 years.
- Market penetration could reach 70%-80% over the next five years, driven by formulary shifts.
- Discounting and rebate practices will influence net prices more than list prices.
- The competitive landscape will tighten, with rapid biosimilar adoption reducing originator revenues.
FAQs
1. How does the price of Kanjinti compare to Herceptin?
Kanjinti's list price in 2023 averages around $2,200-$2,600 per vial, approximately 15%-20% lower than Herceptin's $2,950 per vial, with actual negotiated net prices potentially higher savings.
2. What factors affect biosimilar adoption in the US?
Formulary inclusion, clinician familiarity, payer rebates, contractual agreements, and perceived efficacy influence market penetration.
3. When is the next wave of biosimilar trastuzumab expected to enter?
Additional biosimilars are likely to gain FDA approval by 2024-2025, further increasing competition and reducing prices.
4. How might patent challenges impact biosimilar pricing?
Patent litigation can delay biosimilar market entry or limit their market share, affecting price expectations.
5. What is the outlook for the overall trastuzumab market?
The market will predominantly shift toward biosimilars, with originator revenues declining. Cost savings will drive broader access and usage.
Sources
- IQVIA Institute. “The Use of Biosimilars in Oncology.” 2022.
- FDA. “Kanjinti (trastuzumab-anns) Approval Announcement.” December 2018.
- SSR Health. “Biopharmaceutical Price Trends 2023.”
- National Comprehensive Cancer Network (NCCN). “Herceptin and Biosimilar Utilization Data.” 2022.
- EvaluatePharma. “Oncology Biosimilar Market Projections.” 2023.
