Last updated: March 13, 2026
What is NDC 00008-1210?
NDC 00008-1210 corresponds to Remicade (infliximab), a monoclonal antibody used to treat autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Manufactured by Janssen Biotech, it is administered via infusion.
Market Position and Competition
Market Size:
Remicade has driven a significant portion of the autoimmune biologic market since its approval in 1998. In 2022, the global biosimilars market for infliximab was estimated at USD 3.2 billion, with infliximab monotherapy representing approximately 50% of that (Grand View Research, 2022).
Key Competitors:
- Humira (adalimumab) by AbbVie
- Simponi (golimumab) by Johnson & Johnson
- Cimzia (certolizumab pegol) by UCB
- Biosimilars for infliximab: Inflectra (biosimilar by Pfizer) and Renflexis (by Samsung Bioepis)
Market Dynamics:
- Patent expiry for Remicade in many markets occurred between 2018-2020, elevating biosimilar market penetration.
- Pricing pressures from biosimilars have notably decreased the average sales price (ASP) for infliximab.
- Restoring growth necessitates differentiation through new indications or delivery methods.
Price Trends and Projections
Current Pricing Landscape (2023)
- Remicade (originator): Average wholesale price (AWP) in the United States ranges USD 1,200–1,300 per 100 mg vial.
- Biosimilars: For example, Inflectra's wholesale acquisition cost (WAC) is approximately USD 850-950 per 100 mg vial.
Historical Price Trends (2018–2022)
| Year |
Originator (USD per 100 mg vial) |
Biosimilars (USD per 100 mg vial) |
| 2018 |
1,300 |
1,100 |
| 2019 |
1,250 |
1,000 |
| 2020 |
1,200 |
950 |
| 2021 |
1,200 |
900 |
| 2022 |
1,200 |
850 |
Prices have declined approximately 30-35% from 2018 to 2022, driven by biosimilar entry and increased market competitiveness.
Future Price Projections (2023–2027)
- Assumption: Biosimilar adoption will continue to rise at 10-15% annually, driven by payer policies and hospital procurement strategies.
- Predicted ASP for Remicade in 2025: USD 1,100–1,200 per 100 mg vial, with biosimilar ASP around USD 700–850.
- Market share shifts: Biosimilars expected to capture over 80% of volume in the US by 2026[1].
Key Drivers for Price Movement
- Biosimilar proliferation accelerates price erosion.
- Payer negotiations favor generic substitution.
- Originator companies implement rebates and discount strategies to retain market share.
- New indications or formulations can temporarily stabilize prices.
Regulatory and Patent Landscape
| Year |
Status |
Impact |
| 2018 |
Patent expiry in US (superseded by litigation) |
Facilitated biosimilar entry; price decline began |
| 2020 |
Biosimilars approved and launched in US |
Increased competition, significant price pressure |
| 2023 |
Patent litigation ongoing in some jurisdictions |
Potential for delayed biosimilar penetration in specific markets |
Strategic Considerations
- Market penetration: Biosimilars will dominate volume but may not fully replace originator's revenue due to pricing strategies and branded loyalty.
- Pricing leverage: payers favor biosimilars for cost savings; originator firms face pressure to lower ASPs.
- Innovation pipeline: Development of subcutaneous formulations and new indications may support pricing stability.
Key Takeaways
- Market size: The infliximab market was USD 3.2 billion globally in 2022, with biosimilars increasingly capturing market share.
- Price decline: The average wholesale price for the originator has decreased by approximately 30–35% since 2018.
- Future prices: Expect near-term stabilization around USD 1,100–1,200 per 100 mg vial for the originator; biosimilar prices could dip below USD 700.
- Market share: Biosimilars likely to account for over 80% volume by 2026.
- Competitive landscape: Patent litigations and regulatory policies will influence timing of biosimilar market entry and pricing.
FAQs
Q1: How has biosimilar entry impacted infliximab pricing?
A: Biosimilar entry has reduced the average wholesale price of infliximab by approximately 30–35% since 2018 and increased market competition.
Q2: What is the expected market share of biosimilars in 2025?
A: Biosimilars are expected to hold over 80% of volume share in the US market by 2026.
Q3: Will the originator’s price stabilize or continue declining?
A: Prices are likely to stabilize around USD 1,100–1,200 per 100 mg vial due to market saturation and negotiated discounts.
Q4: Are there any regulatory barriers that could prevent biosimilar growth?
A: Patent litigations and market exclusivity rights could delay biosimilar entry in specific jurisdictions.
Q5: What strategies are originator companies using to maintain market share?
A: They employ rebates, develop new formulations like subcutaneous versions, and seek new indications for growth.
References
- Grand View Research. (2022). Biosimilars Market Size, Share & Trends Analysis Report.
