Last updated: February 22, 2026
What is NDC 00472-1790?
NDC 00472-1790 refers to Humira (adalimumab), a monoclonal antibody used primarily for autoimmune conditions including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. It was first approved by the FDA in 2002 and remains a leading biologic therapy in its class.
Market Landscape Overview
Market Size and Key Players
Humira held a dominant position among biologics for autoimmune conditions. In 2022, the global biologics market for autoimmune diseases was valued at approximately $162 billion.[1] Humira accounted for about 16% of that market, equating to roughly $26 billion in revenue globally.
Primary competitors include:
- Enbrel (etanercept) – Amgen, Pfizer-Samsung Bioepis
- Remicade (infliximab) – Johnson & Johnson
- Skyrizi (risankizumab) – AbbVie
- Cymbalta (duloxetine) – Lilly (though not a biologic, relevant for certain indications)
Patent Expiry and Biosimilar Introduction
Humira faced patent expirations starting in 2018 in various markets. The U.S. market experienced biosimilar entries from Novartis/Sandoz and Amgen in 2023, reducing its market share. Unlike small molecules, biosimilar penetration in biologics is slower due to regulatory and manufacturing complexities.
In the U.S., biosimilar uptake has been gradual:
| Year |
Biosimilar Market Share (U.S.) |
Major Biosimilars Approved |
| 2023 |
20% |
Amjevita (Amgen), Cimerli (Coherus) |
| 2025 |
Expected 35-40% |
Additional entries from Lilly, Biosimilar Alliances |
Global markets, especially in Europe, display higher biosimilar adoption rates, reaching 50-70% in some cases.
Regulatory and Policy Environment
- FDA approved abbreviated biosimilar pathways in 2015.
- The Biologics Price Competition and Innovation Act (BPCIA) incentivizes biosimilar development.
- US Medicare and Medicaid have policies to promote biosimilar adoption, impacting pricing.
Clinical and Market Trends
Increasing use in biosimilars, removal of patient barriers, and expansion into new indications (e.g., hidradenitis suppurativa) sustain the demand. However, market saturation and pressure to reduce prices threaten revenue streams for the originator.
Price Dynamics and Projections
Current Pricing Structure
- Branded Humira (U.S.): List price approximately $6,000 per month per patient (depending on dosage and formulation).
- Biosimilars: Priced 25-35% lower than the originator, with net prices ranging between $4,000 to $4,500 per month.
The average wholesale price (AWP) as of 2023 is:
| Drug |
Monthly Cost |
Approximate Price (U.S.) |
| Humira |
$6,000 |
Baseline |
| Biosimilar (e.g., Amjevita) |
$4,500 |
25% discount |
Price Projections (Next 5 Years)
-
Biosimilar Impact:
- Biosimilars are expected to capture 50-70% of Humira's market share in key regions by 2028.
- List prices for biosimilars may decline further to $3,500 per month, driven by market competition.
-
Originator Price:
- Pfizer and AbbVie have announced voluntary discounts to maintain market share; list prices for Humira could decrease by 10-20% over five years.
- Net prices after rebates and discounts are likely to remain below list prices, averaging $5,000 to $5,500 per month.
-
Market Volume:
- Estimated 6 million patients worldwide use Humira or biosimilars for approved indications.
- Usage expansion into additional indications and off-label applications could offset volume declines caused by biosimilar competition.
Market Revenue Forecast (2023–2028)
| Year |
Projected Revenue (Global) |
Change from 2022 |
| 2023 |
$20 billion |
Baseline |
| 2024 |
$17.5 billion |
-12.5% (biosimilar entry effect) |
| 2025 |
$15 billion |
-25% |
| 2026 |
$12.5 billion |
-37.5% |
| 2027 |
$10 billion |
-50% |
| 2028 |
$8 billion |
Continued decline |
This decline accounts for biosimilar market share growth, patent exclusions, and tiered contracting practices in the US and Europe.
Key Factors Affecting Price and Market Share
- Patent Litigation: Delays in biosimilar approvals in the US prolong originator dominance.
- Reimbursement Policies: Favor biosimilar use in Medicare/Medicaid, reducing prices for originator.
- Manufacturing Costs: Biosimilars' lower production costs allow competitive pricing.
- Innovation Pipeline: New formulations or delivery methods may sustain demand.
Conclusion
Humira (NDC 00472-1790) faces significant price erosion driven by biosimilar competition but maintains revenue through expanded indications and market presence. Prices are expected to decrease substantially in the coming years, with net prices stabilizing around $5,000/month amid shrinking market share.
Key Takeaways
- Humira's revenue peaked at over $20 billion globally in 2022.
- Biosimilars are projected to account for 50-70% of the U.S. market by 2028, reducing average prices.
- List prices for biosimilars may fall below $3,500 per month.
- The overall market for Humira is expected to decline by approximately 60-65% between 2023 and 2028.
- Originator companies will attempt to retain market share via discounts and new indications.
FAQs
Q1: How does biosimilar entry impact Humira's pricing?
A: Biosimilar entry typically drives down list and net prices, with discounts of 25-35%, leading to increased market competition.
Q2: What are the primary indications for NDC 00472-1790?
A: Rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa.
Q3: When will biosimilars significantly reduce Humira’s market share?
A: US biosimilars are expected to reach 50-70% market share by 2028.
Q4: What are the future price projections for Humira in the US?
A: List prices may decline by 10-20% over five years, with net prices hovering around $5,000 to $5,500 per month.
Q5: Are there opportunities for new indications to sustain revenue?
A: Yes; expanding into additional autoimmune conditions can help maintain demand despite biosimilar competition.
References
[1] EvaluatePharma. (2022). Biologics market data. Retrieved from https://www.evaluate.com
