Last updated: March 9, 2026
What is the active ingredient and approved indication?
NDC 51862-0884 corresponds to a biosimilar product of the originator biologic, infliximab. The product targets autoimmune conditions, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriasis. The biosimilar was approved by the FDA in 2016 under the name Inflectra (infliximab-dyyb).
Market size and competitive landscape
Current market size
- The global infliximab market was valued at approximately $8.5 billion in 2022.
- North American sales account for about 60% of the market, driven by high prevalence of autoimmune conditions.
- The US infliximab market generated around $5.1 billion in 2022, primarily composed of the originator Remicade (Johnson & Johnson).
Key competitors
| Product |
Manufacturer |
Year of Approval |
Market Share (2022) |
Price (per 100 mg vial) |
| Remicade (Infliximab) |
J&J |
1998 |
70% |
$1,200 |
| Inflectra (Infliximab-dyyb) |
Pfizer |
2016 |
15% |
$850 |
| Renflexis (Infliximab-abda) |
Samsung Bioepis |
2017 |
10% |
$870 |
Note: Biosimilar prices are approximately 25-30% lower than originators. Newer biosimilars like CT-P13 (Remsima) hold minor market shares.
Market growth drivers
- Patent expiry of Remicade in 2018 in the US, opening market share for biosimilars.
- Patent litigations primarily settled by 2020, increasing biosimilar penetration.
- Growing adoption of biosimilars due to cost-saving pressures on healthcare providers and payers.
Price trajectory and projections
Historical trends
- Biosimilar infliximab launched in 2016 at roughly 30% lower than Remicade.
- Prices declined approximately 20% in the US market over the subsequent three years.
- Rebasing or volume discounts further pressured list prices, especially in institutional settings.
Future pricing outlook (2023-2027)
| Year |
Estimated Average Price (per 100 mg vial) |
Rationale |
| 2023 |
$825 |
After initial adoption, prices stabilize with marginal declines. |
| 2024 |
$800 |
Continued price competition and volume-based discounts. |
| 2025 |
$775 |
Increased biosimilar market share compresses margins. |
| 2026 |
$750 |
New biosimilars dilute the market, pushing prices lower. |
| 2027 |
$725 |
Broader formulary acceptance and volume growth support further declines. |
The price decline rate is estimated at approximately 2-3% annually from 2023 onward. Factors potentially accelerating this trend include increased biosimilar approvals, payer pressure, and consolidation among healthcare providers.
Regulatory and policy influences
- The Biologics Price Competition and Innovation Act of 2009 facilitated biosimilar entry, with multiple biosimilars approved since 2016.
- CMS and private insurers increasingly prefer biosimilars to contain costs, affecting formulary decisions.
- State legislation in certain US regions promotes interchangeability and substitution, potentially influencing biosimilar market share.
Geographic considerations
- US remains the largest market for infliximab biosimilars due to high autoimmune disease prevalence.
- Europe features active biosimilar uptake, with price discounts of 40-50% relative to originator.
- Emerging markets demonstrate slower adoption, often constrained by regulatory and reimbursement hurdles.
Key factors impacting future market and prices
- Patent litigations, including patent disputes regarding manufacturing processes.
- Introduction of next-generation biosimilars with enhanced features.
- Regulatory decisions on interchangeability statuses.
- Payer and provider acceptance influencing market penetration.
- Manufacturing costs, particularly with bioreactor and supply chain efficiencies.
Summary
NDC 51862-0884, as a biosimilar infliximab, operates within a mature but still growing market. It faces pricing pressures from increasing biosimilar competition. Prices are projected to fall gradually over the next five years, stabilizing around $725 per 100 mg vial by 2027. Market share expansion will depend on formulary acceptance, regulatory developments, and broader healthcare policy incentives.
Key Takeaways
- The biosimilar market for infliximab has rapidly expanded since 2016, capturing significant share from the originator.
- US prices for infliximab biosimilars are expected to decline 2-3% annually through 2027.
- Market share growth hinges on regulatory acceptance and payer policies prioritizing cost savings.
- Patent disputes and regulatory considerations remain pivotal in shaping future competition.
- Price reductions will be constrained by manufacturing costs and global market dynamics.
FAQs
-
What is the current market share of biosimilar infliximab products?
Biosimilars hold approximately 25-30% in the US infliximab market as of 2022, with scope for growth.
-
How do biosimilar infliximab prices compare to the originator?
Biosimilar prices are about 25-30% lower than Remicade, with ongoing declines anticipated.
-
What are key factors influencing biosimilar adoption?
Regulatory approvals, interchangeability policies, payer incentives, and clinician acceptance.
-
What role do patent litigations play in market dynamics?
Patent disputes delay biosimilar entry and can influence pricing and market share when resolved.
-
How might new biosimilars impact prices?
Increased competition from additional biosimilars could push prices further downward and accelerate market share shifts.
References
[1] IQVIA. (2023). Prescription drug market analytics.
[2] FDA. (2016). Infliximab biosimilar approval announcement.
[3] Pharma Intelligence. (2022). Global biosimilar market analysis.
[4] Centers for Medicare & Medicaid Services. (2023). Biosimilars policies and reimbursement.
[5] Sandoz. (2022). Pricing strategies for biosimilars.
