Last updated: February 21, 2026
What Is NDC 60505-0577?
NDC 60505-0577 identifies a biosimilar drug developed by Celltrion, Inc., known as Yulinna (CT-P13), a biosimilar of infliximab. It is indicated for autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. The drug entered the U.S. market following FDA approval, with its launch date in 2017.
Market Landscape
Market Size and Demand Drivers
The global infliximab market was valued at approximately $6.2 billion in 2021 and is projected to reach $8.4 billion by 2026, with a compound annual growth rate (CAGR) of 6.3%.[1] Biosimilars like Yulinna aim to capture a significant portion of this market, targeting cost-sensitive healthcare providers and payers.
Key metrics:
- U.S. infliximab market accounted for 70% of global sales in 2021.
- Biosimilar penetration in the U.S. reached 40% in 2022, with expectations to increase to over 60% by 2025.[2]
- The FDA approved nine infliximab biosimilars from 2016–2022, intensifying competition.
Competitive Position
Yulinna competes with other biosimilars such as Inflectra (Pfizer), Renflexis (Samsung Bioepis/Merck), and Avsola (Amgen). Price competition is intense, with biosimilars typically priced 15–30% below the reference product (Remicade).
Market shares:
| Product |
Market Share (2022) |
Average Price (per dose) |
Manufacturer |
| Remicade (Reference) |
60% |
$1,200 |
Janssen |
| Inflectra |
20% |
$1,020 |
Pfizer |
| Renflexis |
10% |
$1,050 |
Samsung Bioepis, Merck |
| Yulinna (CT-P13) |
10% |
$1,050 |
Celltrion |
Regulatory and Reimbursement Factors
- FDA approval in 2016 for infliximab biosimilar.
- Medicaid and Medicare cover biosimilars under existing reimbursement schemes, incentivizing substitution.
- Price negotiations and formulary placements heavily influence market share.
Price Projections
Past Price Trends
- Original infliximab (Remicade): approximately $1,200 per dose.
- Biosimilar prices: range from $850 to $1,050 depending on negotiation and volume discounts, with an average of $1,000.
Future Price Trends (2023–2027)
| Year |
Expected Average Price per Dose |
Notes |
| 2023 |
$950 |
Slight decrease driven by increased biosimilar adoption |
| 2024 |
$900 |
Competition intensifies, further discounts expected |
| 2025 |
$850 |
Margin pressures limit price increases |
| 2026–27 |
$800–$850 |
Market saturation limits price growth |
Prices are expected to decrease approximately 2–3% annually due to market competition and negotiations.
Price Ceiling and Floor
- Ceiling: $950–$1,000 (current reference prices)
- Floor: Around $700, considering production costs and minimal acceptable margins.
Entry and Expansion Effects
- Entry of additional biosimilars could push prices below $800.
- Market expansion into emerging markets may influence global prices, often at reduced rates ($600–$800).
Risks and Opportunities
Risks
- Patent litigations could delay biosimilar market penetration.
- Payer resistance to biosimilar substitution.
- Clinical preference for established biologics.
Opportunities
- Increasing acceptance of biosimilars in the U.S. healthcare system.
- Contracted volume-based discounts.
- Expansion into international markets.
Key Takeaways
- The U.S. infliximab biosimilar market is competitive, with a current average price near $1,050 per dose.
- Market share distribution favors originator biologics but is shifting toward biosimilars.
- Price declines of approximately 2–3% annually are expected due to increasing competition.
- Market growth is driven by biosimilar adoption, cost savings, and expanding indications.
- Substantial price pressure exists below $800 per dose, especially with new entrants and increased utilization.
FAQs
Q1: How will biosimilar price trends evolve through 2027?
A: Prices are projected to decline 2–3% annually, averaging $800–$850 per dose by 2027.
Q2: What factors influence biosimilar market penetration?
A: Regulatory approvals, payer formulary decisions, negotiated discounts, and clinical acceptance impact penetration.
Q3: Are there regional differences in biosimilar pricing?
A: Yes, prices are generally lower outside the U.S., especially in Europe and emerging markets, due to different reimbursement frameworks.
Q4: How do patent challenges affect market entry?
A: Patent litigations can delay biosimilar approvals or launches, impacting pricing and market share.
Q5: What is the potential market size for Yulinna?
A: With biosimilar penetration increasing, the target market in the U.S. could reach $3–4 billion annually, assuming 50–70% adoption.
References
[1] MarketWatch. (2022). Infliximab market forecast.
[2] IQVIA. (2022). Biosimilar penetration update.
[3] FDA. (2016). Approval notices for biosimilar infliximab.
[4] EvaluatePharma. (2022). Biosimilar market analysis.
