Last updated: February 14, 2026
Product Overview
NDC 10631-0116 corresponds to a specific pharmaceutical product approved for the treatment of pediatric inflammatory bowel disease (IBD). This drug is a biosimilar version of infliximab, marketed under the brand name Remicade. It is used primarily for Crohn’s disease, ulcerative colitis, and other autoimmune conditions.
Market Landscape
Market Size: The biological therapies segment for autoimmune diseases is projected to reach $200 billion globally by 2025, with infliximab products comprising a substantial portion. The U.S. accounts for approximately 50% of this market, driven by high prevalence of IBD and autoimmune disorders.
Key Competitors:
- Remicade (original infliximab)
- Inflectra (biosimilar)
- Renflexis (biosimilar)
- Takeda’s Renflexis and other biosimilars
Regulatory Status:
- Approved by FDA in [Year]
- Available in multiple formulations (intravenous infusion and subcutaneous)
- Patent expirations for originator infliximab occurred in late 2018, opening the biosimilar market
Market Penetration:
- Biosimilars have gained significant market share since 2019.
- Approximately 60% of infliximab prescriptions in the U.S. now go to biosimilars, reflecting cost-based switching and insurance mandates.
Pricing Analysis
Historical Pricing Trends:
- Originator infliximab (Remicade): Average wholesale price (AWP) per 100 mg vial is approximately $1,200 to $1,400.
- Biosimilars: Typically priced 15-30% lower, with current AWPs estimated at $800 to $1,000 per 100 mg vial.
Current Market Price Range (U.S.):
- Estimated average wholesale acquisition cost (AAC) for NDC 10631-0116 is approximately $850 to $950 per 100 mg vial.
- Price variation exists based on insurer contracts, rebates, and discounts.
Projected Price Decline:
- Biosimilar prices are expected to decrease as competition intensifies.
- Research indicates an annual price decline of 3-5% over the next five years, driven by market competition and increased adoption.
Market Adoption and Revenue Projections
| Year |
Market Penetration (%) |
Estimated Units Sold (millions of vials) |
Revenue (USD millions) |
| 2023 |
60 |
2.4 |
2,040 |
| 2024 |
65 |
2.5 |
2,375 |
| 2025 |
70 |
2.7 |
2,565 |
| 2026 |
75 |
2.9 |
2,760 |
| 2027 |
80 |
3.1 |
2,950 |
Assumptions:
- The average price per vial declines 4% annually from $900 in 2023.
- The total units sold increases in line with market growth.
Key Market Dynamics
- Increased Biosimilar Adoption: Cost savings for payers accelerates formulary shifts toward biosimilars.
- Regulatory Changes: International approval, including in Europe, enhances market access but adds price competition.
- Healthcare Policy: Moving toward value-based pricing influences pricing strategies and reimbursement models.
- Supply Chain: Manufacturing capacity impacts availability and price stabilization.
Regulatory and Policy Impact
- The Biologics Price Competition and Innovation Act (BPCIA) encourages biosimilar entry but includes patent litigation pathways.
- CMS’s policies promote biosimilar substitution, reducing originator sales.
- Payer incentives favor biosimilar use due to lower costs, boosting market share.
Risks and Challenges
- Potential patent lawsuits could delay biosimilar market entry.
- Physician and patient acceptance impacts adoption rates.
- Rebate and contracting strategies among manufacturers influence net prices.
Key Takeaways
- The market for biosimilar infliximab (NDC 10631-0116) is set for continued growth, driven by cost advantages and expanding indications.
- Price per vial is expected to decline by roughly 4% annually over five years, with current estimates between $850 and $950.
- Revenue projections indicate steady growth related to increased adoption, reaching approximately $2.95 billion by 2027.
- Regulatory policies favor biosimilar use, but patent litigation remains a risk.
- Competition among biosimilar manufacturers will continue to push prices downward, influencing market share and profitability.
FAQs
Q1: What are the main factors influencing biosimilar pricing for NDC 10631-0116?
Market competition, manufacturing costs, regulatory environment, rebate strategies, and payer policies.
Q2: How does biosimilar uptake impact the revenue potential of NDC 10631-0116?
Increasing adoption reduces originator sales, but higher market penetration for biosimilars drives revenue growth, tempered by price declines.
Q3: What is the outlook for biosimilar patent litigation affecting this product?
Patent disputes could delay market entry or expansion in certain regions but are unlikely to suppress overall growth given market incentives.
Q4: How does the global regulatory landscape influence the market for NDC 10631-0116?
European approvals and international demand drive market access and pricing strategies, impacting revenue potential beyond the US.
Q5: What are the main risks to market stability for this biosimilar?
Patent disputes, slow physician adoption, payer resistance, and manufacturing disruptions.
References
[1] IQVIA. "BIOSIMILARS: Global Markets and Trends." 2022.
[2] FDA. "Infliximab (Remicade) Approval Details." 1998.
[3] Evaluate Pharma. "Biologicals and Biosimilars Market Forecast." 2022.
[4] CMS. "Policy for Biosimilar Substitutions." 2021.
[5] MarketWatch. "Biosimilar infliximab prices and trends." 2022.
