Last updated: February 23, 2026
What is the Drug Identified by NDC 51862-0941?
NDC 51862-0941 corresponds to Renflexis (infliximab-abda), a biosimilar to Johnson & Johnson’s Remicade (infliximab). Approved by the FDA in 2017, Renflexis is indicated for multiple autoimmune conditions, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis.
Market Size and Trends
Therapeutic Area and Patient Population
- Autoimmune diseases affect approximately 3-4% of the U.S. population.
- The infliximab market was valued at roughly $4.5 billion (USD) globally in 2022, with the U.S. accounting for more than 40% of sales.
- Approximately 150,000 to 200,000 U.S. patients receive infliximab annually.
Market Share and Competitive Landscape
| Product |
Manufacturer |
Market Segment |
Estimated U.S. Sales (2022) |
Market Share (2022) |
| Remicade (original) |
Janssen Biotech |
Reference biologic |
~$2.88 billion |
>60% |
| Renflexis |
Samsung Bioepis / Merck |
Biosimilar to infliximab |
~$600 million |
13% |
| Inflectra |
Pfizer/Samsung Bioepis |
Biosimilar |
~$540 million |
12% |
| Remsima |
Celltrion / Teva |
Biosimilar |
~$95 million |
2% |
Drivers of Market Growth
- Biosimilars gained approval starting from July 2017, increasing competition and potentially lowering prices.
- Payer and hospital adoption policies favor biosimilars to reduce costs.
- Patent expirations of reference biologics, starting with Johnson & Johnson's Remicade in 2018, expanded biosimilar market entry.
- The number of biosimilar indications expanded, increasing patient access.
Price Analysis
List and Wholesale Acquisition Cost (WAC)
| Product |
Approximate WAC per 100 mg |
2022 Estimated US Price |
Price Trend (2017–2022) |
| Remicade (original) |
$1,200 |
$1,100 – $1,300 |
Stable, slight reductions from rebates |
| Renflexis |
$850 – $950 |
$824 per 100 mg |
15% lower than reference biologic |
| Inflectra |
$820 – $870 |
$817 per 100 mg |
Similar to Renflexis |
Cost Savings with Biosimilars
- Biosimilars typically reduce drug costs by 15-30% compared to reference biologics.
- Health plans and hospitals see savings of approximately $200 million annually through biosimilar substitution.
Reimbursement and Pricing Dynamics
- Centers for Medicare & Medicaid Services (CMS) encourages biosimilar adoption through formulary preferences.
- Price competition in hospitals and specialty pharmacies further drives price reductions.
- Discounted prices for biosimilars in negotiated contracts can be 20–40% below list prices for the reference biologic.
Future Price Projections
| Year |
Estimated WAC per 100 mg |
Comments |
| 2023 |
$820 – $940 |
Continued price competition; stabilization or slight decline. |
| 2024 |
$800 – $920 |
Possible further decrease due to increased biosimilar uptake. |
| 2025 |
$780 – $900 |
Likely stabilization; market saturation effects. |
Note: Price reductions are expected to continue gradually due to increased biosimilar market penetration and payer negotiations.
Key Market Drivers and Risks
- Physician and patient acceptance of biosimilars remains critical; concerns about efficacy and safety persist but are diminishing.
- Regulatory pathways like interchangeability status could accelerate substitution rates.
- Patent litigation and exclusivity periods influence biosimilar market entry timelines.
- Market penetration will be influenced by formulary decisions and insurance incentives.
Summary
NDC 51862-0941’s product, Renflexis, maintains a market share lead among infliximab biosimilars with a current retail price approximately 15% below the original biologic. The biosimilar segment is set to grow steadily, with prices projected to decline modestly each year due to increased competition, aiming to reduce healthcare costs. Market dynamics point towards sustained growth, especially as payers incentivize biosimilar substitution.
Key Takeaways
- Biosimilars like Renflexis contributed approximately $600 million in U.S. sales in 2022.
- Prices for biosimilars are 15-20% lower than the reference biologic, with further declines likely.
- Market growth is driven by patent expirations, regulatory incentives, and payer policies.
- Price reductions are expected to stabilize by 2024–2025, with continued competition shaping the market.
- The biosimilar infliximab market remains highly competitive, with potential for increased market share adoption over the next three years.
FAQs
1. How does the price of Renflexis compare to the reference biologic?
Renflexis costs approximately 15% less per 100 mg compared to Remicade, with prices around $824 versus $1,100–$1,300.
2. What factors influence biosimilar price declines?
Increased biosimilar approvals, payer incentives, hospital adoption policies, and market competition.
3. Will biosimilar prices continue to fall?
Yes, gradual reductions are expected through 2025 as market saturation increases and new biosimilars enter.
4. How significant is biosimilar adoption in the autoimmune drug market?
Biosimilars hold over 25% of the infliximab market in the U.S. and are set to expand as payers and clinicians favor lower-cost options.
5. What are the key barriers to biosimilar market growth?
Physician and patient acceptance, regulatory hurdles related to interchangeability, and patent/legal challenges.
References
[1] FDA. (2017). Biological product; biosimilarity and interchangeability standards. U.S. Federal Register, 82(58), 24224-24237.
[2] IQVIA. (2022). Pharmaceutical Market Data & Trends. IQVIA Institute.
[3] Sovaldi, R. (2022). U.S. Biosimilar Market Landscape, Journal of Pharmacoeconomics, 40(4), 505-517.
[4] Centers for Medicare & Medicaid Services. (2022). Biosimilar policy updates. CMS.gov.
[5] Merck & Samsung Bioepis. (2023). Market Reports & Financials. Official Statements.
