Last updated: February 16, 2026
Product Overview
NDC 00555-0607 corresponds to a biosimilar version of infliximab, a monoclonal antibody used primarily for autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. This biosimilar entered the U.S. market around 2018, with several competitors available.
Market Size and Demand Drivers
The infliximab market in the U.S. was valued at approximately $7 billion in 2022, with biological therapies representing the majority of revenue. Biosimilars have gained traction because of their lower price point, leading to increased adoption in cost-sensitive healthcare settings.
Key demand drivers include:
- Expiration of originator patents (Remicade by J&J)
- Physician and payer acceptance of biosimilars
- Policy pushes incentivizing biosimilar use (e.g., CMS reimbursement policies)
- Increasing prevalence of autoimmune conditions
In 2022, biosimilars accounted for about 20% of infliximab prescriptions, with this figure projected to reach 40% by 2025[1].
Market Competition
NDC 00555-0607 faces competition from:
- Remicade (original biologic)
- Other biosimilars such as infliximab-dyyb (Inflectra), infliximab-abda (Renflexis), and infliximab-axp (Ixifi)
Sales are concentrated among the top three biosimilars, which together account for roughly 75% of biosimilar infliximab prescriptions. A few key factors influence market share:
- Formulation and administration convenience
- Physician familiarity and brand loyalty
- Price differences among biosimilars
Pricing Landscape
List prices for infliximab biosimilars vary from roughly $800 to $1,200 per vial, compared to about $3,000 per vial for the originator. Actual net prices depend on contractual discounts, rebates, and payer negotiations.
Historical Price Trends
Since biosimilar launches:
- Initial discounts ranged from 15% to 30% below the branded biologic.
- Average net prices for biosimilars have declined 10% annually, largely due to increased competition and payer pressure.
- By 2022, the average biosimilar price was approximately 55-65% lower than the original biologic.
Price Projections (2023-2028)
Assuming competitive dynamics continue:
- The average biosimilar infliximab price is expected to stabilize around $700 to $900 per vial.
- Price erosion is likely to slow as the market matures, with minimal further discounts past 2025.
Projected Market Penetration & Revenue
By 2028:
- Biosimilar infliximab could account for 50-60% of infliximab prescriptions.
- Annual sales of biosimilar infliximab are estimated to reach $2.5 to $3 billion, up from about $1.2 billion in 2022[2].
Regulatory and Policy Impact
Efforts to promote biosimilar uptake will influence prices and market share. Policies encouraging interchangeability and increased physician prescribing of biosimilars are expected to exert downward pressure on prices.
Risks and Opportunities
Risks:
- Market saturation leading to price stabilization
- Potential for new competitors or slight modifications driving additional discounts
- Regulatory hurdles impairing market access
Opportunities:
- Expansion into outpatient and international markets
- Use of biosimilar consolidation strategies to reduce costs
- Payer inclusion in value-based contracts that incentivize biosimilar use
Key Takeaways
- NDC 00555-0607, as a biosimilar infliximab, operates within a $7 billion market, with rapid adoption driven by cost savings and policy initiatives.
- The average price per vial is expected to hover around $700-$900 through 2028, with sales increasing substantially as biosimilar penetration grows.
- Market share expansion is limited by existing competition and market maturity, but biosimilars will remain a significant segment of infliximab prescriptions.
- Price erosion by more than 50% relative to the originator is unlikely past 2025; stabilization is projected thereafter.
Frequently Asked Questions (FAQs)
1. What factors influence the pricing of biosimilar infliximab?
Pricing depends on manufacturing costs, competitive dynamics, negotiated discounts, and payer reimbursement policies. The entry of new biosimilars and evolving policies tend to drive prices downward.
2. How does biosimilar penetration impact the overall market?
Increased biosimilar adoption reduces treatment costs, leading to expanded patient access and market share redistribution among infliximab competitors.
3. Are there any upcoming regulatory changes that could impact prices?
Future guidance on interchangeability and policies promoting biosimilar prescribing may further accelerate adoption and influence prices.
4. What are the main barriers to biosimilar uptake?
Physician familiarity, perceived efficacy concerns, and payer incentives favoring originators remain barriers. Contractual or formulary restrictions may also limit biosimilar prescribing.
5. How does international market access differ from the U.S.?
Global markets, especially in Europe, exhibit higher biosimilar penetration due to different regulatory environments, pricing regulations, and healthcare systems.
Citations
[1] IQVIA. "U.S. Biosimilars Market Report," 2022.
[2] Evaluate Pharma. "Infliximab Biosimilar Sales & Market Share Data," 2022.
