Last updated: February 27, 2026
What is NDC 62135-0892?
NDC 62135-0892 corresponds to a drug marketed by Celltrion Healthcare. It is a biosimilar product, specifically a biosimilar of infliximab (Remicade). The product is used to treat autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
Market Overview
Market Size and Growth
The global biosimilars market was valued at approximately USD 25 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8.5% through 2030, reaching USD 60 billion.
Key drivers include increasing biologic drug patent expirations, rising adoption of biosimilars, and regulatory support.
Key Competitors and Market Share
Major biosimilar competitors to infliximab include:
| Product name |
Manufacturer |
Approval Year |
Market Share (2022) |
Price Difference versus Innovator |
| Inflectra |
Celltrion, Pfizer |
2016 |
35% |
15-25% lower |
| Renflexis |
Samsung Bioepis, Merck |
2017 |
20% |
20-30% lower |
| Flixabi |
Sandoz |
2018 |
10% |
20-35% lower |
| Svzo |
Coherus |
2021 (pending) |
5% |
15-20% lower |
Regulatory Environment
US Food and Drug Administration (FDA) approved the biosimilar in 2016. European Medicines Agency (EMA) approved biosimilar infliximab products starting in 2013. Variability in acceptance and reimbursement policies across regions influences sales volumes.
Reimbursement Landscape
Biosimilar adoption depends heavily on reimbursement policies. Countries with strict biosimilar substitution policies or cost-containment strategies accelerate prices and market penetration.
Price Projections
Current Pricing Dynamics
As of 2023, the average list price for biosimilar infliximab is approximately USD 3,000 - USD 5,000 per treatment cycle, compared to the USD 10,000+ for the reference product.
Price Trends (2023-2027)
| Year |
Average Biosimilar Price |
Price Reduction from 2022 |
Volume Growth Rate |
Total Market Value Estimate |
| 2023 |
USD 3,000 - USD 5,000 |
10-15% lower |
20% increase |
USD 1 billion |
| 2024 |
USD 2,800 - USD 4,500 |
10% lower |
25% increase |
USD 1.25 billion |
| 2025 |
USD 2,600 - USD 4,000 |
12% lower |
30% increase |
USD 1.6 billion |
| 2026 |
USD 2,400 - USD 3,800 |
12% lower |
35% increase |
USD 2 billion |
| 2027 |
USD 2,200 - USD 3,600 |
13% lower |
40% increase |
USD 2.8 billion |
Key Factors Depressing Prices
- Increased biosimilar competition is driving prices downward.
- Regulations promoting automatic substitution in certain markets.
- Cost containment policies across healthcare systems.
Factors Potentially Supporting Price Stability
- Supply chain disruptions increasing manufacturing costs.
- Patent litigations delaying market entry of some biosimilars.
- Higher demand in emerging markets leading to stable volumes, limiting price discounts.
Strategic Implications
- Volume expansion is critical, as prices are expected to decline steadily.
- Market entry and promotion strategies should focus on regions with favorable reimbursement policies.
- Production cost reductions can sustain margins amid declining prices.
- Track regulatory developments that impact biosimilar reimbursement.
Key Takeaways
- Biosimilar of infliximab (NDC 62135-0892) faces a competitive landscape dominated by multiple manufacturers.
- Prices are projected to decline steadily from USD 3,000 to USD 2,200 by 2027.
- Market volume is expected to grow by 20-40% annually, elevating total market value to nearly USD 3 billion.
- Policy environment varies by region, affecting adoption rates and pricing.
- Strategic focus on cost reduction and regulatory navigation can optimize profitability.
FAQs
Q1: What are the primary uses for this biosimilar?
It treats autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
Q2: How does the price of biosimilar infliximab compare to the originator?
Biosimilars generally cost 15-35% less, with current averages around USD 3,000-USD 5,000 per cycle versus USD 10,000+ for the originator.
Q3: Which markets are most conducive to biosimilar infliximab growth?
Europe and emerging markets with supportive reimbursement policies have higher adoption rates.
Q4: What factors could influence price trends beyond 2027?
Patent disputes, new regulatory policies, and shifts in market demand could alter pricing trajectories.
Q5: What strategies can companies use to succeed in this market?
Focus on cost-efficient manufacturing, engaging with policymakers, and expanding into regions with favorable biosimilar policies.
References
[1] MarketsandMarkets. (2022). Biosimilars Market by Product, Application, End User - Global Forecast to 2030.
[2] IQVIA. (2022). Global Use of Biosimilars report.
[3] U.S. Food and Drug Administration (FDA). (2016). Approval of Celltrion's infliximab biosimilar.
[4] European Medicines Agency (EMA). (2013-2021). Biosimilar infliximab approvals.
