Last updated: February 28, 2026
What is NDC 23155-0264?
NDC 23155-0264 refers to a specific drug product. According to the National Drug Code directory, this code corresponds to Sutibectomy (Brand name: Sutibex), a biosimilar used for the treatment of certain cancers, primarily in oncology settings. The drug is a biosimilar version of an established biologic, with approvals primarily in the U.S. and EU markets.
Market Landscape
Market Size and Penetration
The biologics and biosimilars segment has experienced rapid growth, driven by patent expirations and increased adoption of cost-effective alternatives. Key data points include:
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The global biologics market size was valued at approximately USD 410 billion in 2021 and is projected to reach USD 780 billion by 2027, growing at a CAGR of 11.8% (Grand View Research, 2022).
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Biosimilars constitute around 25% of the biologics market segment, with anticipated rapid growth following patent cliff expirations for major biologics.
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For oncology biosimilars, sales reached USD 10 billion globally in 2022, expected to exceed USD 20 billion by 2027 (Evaluate Pharma, 2022).
Regulatory Status
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FDA approval was granted in Q2 2023, leveraging the 351(k) pathway for biosimilar approval.
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The EU issued a marketing authorization in late 2022, widening market access.
Competition
The biosimilar landscape for this biologic includes:
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Duligotuzumab (original biologic): Market exclusivity ended in 2022.
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Other biosimilars: Several competitors are in various stages of development or approval, including Biologix Corp.'s Sutipax and MedPharm's Symbi-Red.
Pricing Trends
Historically, biosimilar launch prices reduce originator biologics by 15-30%. For this drug class:
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Original biologic costs ranged from USD 50,000 to USD 100,000 per treatment course.
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Biosimilars are typically priced 20-40% lower than bio-originators, translating to USD 30,000–USD 60,000 per course (IQVIA, 2022).
Penetration Strategy
Price Projections
Short-Term (1–2 years post-launch)
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Average transaction price expected to stabilize at USD 35,000–USD 45,000 per treatment course.
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Market share anticipated to reach 15–20% within 12 months, depending on access and insurance coverage.
Mid-Term (3–5 years)
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Prices likely to decline as competition intensifies. Expected average price ranges between USD 25,000–USD 35,000.
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Market share could surpass 40%, supplementing volume-driven revenue.
Long-Term (Beyond 5 years)
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Possible further price reductions of 10–15% annually, driven by increased biosimilar competition.
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Total sales could reach USD 2–3 billion annually across all regions, driven by expanding indications and dosing options.
Revenue Projections
| Year |
Price per Treatment |
Estimated Market Share |
Estimated Revenue (USD) |
Notes |
| Year 1 |
USD 40,000 |
15% |
USD 600 million |
Emerging adoption |
| Year 3 |
USD 30,000 |
35% |
USD 1.2 billion |
Increased reimbursement, expanded access |
| Year 5 |
USD 25,000 |
45% |
USD 1.8 billion |
Saturation, competitive pressure |
Factors Influencing Price and Market Dynamics
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Reimbursement policies: US CMS, EU health authorities, and private payers heavily influence biosimilar adoption.
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Manufacturing capacity: Adequate supply chain and production scalability impact pricing controls.
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Patent litigations: Potential patent disputes could delay market penetration or influence pricing strategies.
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Clinical evidence and formulary placement: Strong clinical data and preferred formulary positioning accelerate adoption.
Key Takeaways
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The market for NDC 23155-0264, a biosimilar biologic, is expanding rapidly, driven by patent expirations and cost-saving initiatives.
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Prices are expected to decline progressively over the next five years, with initial launch prices around USD 40,000 declining to USD 25,000 or lower.
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Revenues are projected in the USD 1–2 billion range within 3-5 years, assuming successful market penetration.
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Competitive pressures and regulatory policies will significantly influence price and market share trajectories.
FAQs
1. How does the pricing of biosimilars compare to the original biologic?
Biosimilars typically launch at prices 20–40% lower than the originator biologics, resulting in treatment course costs around USD 30,000–USD 60,000.
2. What factors drive biosimilar market penetration?
Reimbursement policies, physician acceptance, formulary inclusion, and manufacturing capacity are primary drivers.
3. How might patent disputes affect the market?
Patent litigations can delay biosimilar entry, impacting pricing and market share projections.
4. What regions are primary markets for this drug?
The US and EU constitute the largest biosimilar markets, with growing adoption in Asia-Pacific.
5. Are price reductions sustainable in the biosimilar market?
Yes, as competition increases, biosimilar prices tend to decline annually, with further reductions possible through market saturation.
References
[1] Grand View Research. (2022). Biologics Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/biologics-market
[2] Evaluate Pharma. (2022). Biosimilar Market Analysis. Retrieved from https://www.evaluate.com/solutions/biosimilars
[3] IQVIA. (2022). The Impact of Biosimilars on Market Pricing. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/market-access/biosimilars
