Last updated: February 27, 2026
What is NDC 00093-8310?
NDC 00093-8310 is marketed as Humira (adalimumab), a monoclonal antibody used primarily for autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and other inflammatory disorders. As one of the top-selling biologics globally, Humira commands significant market attention.
Market Overview
Global Revenue and Market Share
Humira was the best-selling drug globally, generating approximately $21.2 billion in sales in 2022[1]. Its market share comprises a substantial portion of the biologic auto-immune treatment segment.
Competitive Landscape
Humira faces competition mainly from biosimilars and other biologics:
| Product |
Type |
Launch Year |
Market Position |
Approximate Global Sales (2022) |
| Humira (adalimumab) |
Original biologic |
2002 |
Market leader, dominates autoimmune indications |
$21.2 billion |
| Amgevita (adalmimumab) |
Biosimilar |
2018 |
Significant market share in Europe, US soon |
$1.2 billion |
| Imraldi (adalimumab) |
Biosimilar |
2018 |
European market, growing presence |
$0.8 billion |
| Cyltezo (adalimumab) |
Biosimilar |
2017 |
US market, expanding |
$0.5 billion |
The entry of biosimilars in the US starting in 2023, following patent expirations, is expected to pressure pricing and market share for Humira.
Patent Expiration Timeline
Humira’s primary US patent expired in January 2023, with additional patent protections ending in 2024. This led to a significant increase in biosimilar competition starting in 2023[2].
Market Dynamics
- Price erosion: Biosimilars entering the US in 2023 caused direct price reductions, estimated at 15–25% for biosimilar versions.
- Physician adoption: Many prescribers still favor Humira due to brand loyalty, but biosimilar uptake is accelerating.
- Market penetration: Biosimilars can capture 30–50% of Humira's original volume within 2 years post-expiration.
Price Projections
Current Pricing Structure
| Region |
List Price (per 40 mg pen, USD) |
2022 Sales (USD billion) |
| US |
~$5,100 |
$21.2 |
| Europe |
~€600 (~$630) |
Data not exact; significant volume |
Note: Steroid- and biosimilar discounts are common, especially in Europe.
Short-term Projections (Next 2 Years)
- US: With biosyramidmarket intensifying, the average net price of Humira is expected to decrease to $3,800–$4,100 per 40 mg pen by 2024[3].
- Europe: Prices will decline 10-15%, influenced by biosimilar competition but less steep than in the US.
Long-term Price Trajectory (2024–2028)
- Price stabilization to around $3,500–$4,000 in the US, due to ongoing biosimilar market share.
- Revenue impact: Humira sales are projected to decline 40–50% over five years, considering biosimilar penetration and market saturation.
Revenue Forecasts
| Year |
Projected US Sales (USD billion) |
Projected Europe Sales (USD billion) |
Total Global Sales (USD billion) |
| 2023 |
~$8.5–$10 billion |
~$8 billion |
~$20 billion |
| 2025 |
~$7.5–$8.5 billion |
~$6.5 billion |
~$15 billion |
| 2028 |
~$5–$6 billion |
~$4.5 billion |
~$10 billion |
Source of projections: EvaluatePharma, IQVIA, and industry analyst reports[4][5].
Key Factors Influencing Price and Market Dynamics
- Patent litigation and legal delays: Patent disputes could temporarily delay biosimilar market entry.
- Regulatory policies: US and EU biosimilar approval pathways and rebate policies influence prices.
- Manufacturing capacity: Biosimilar producers expanding capacity will accelerate price declines.
- Physician and patient acceptance: Payer preferences in adopting biosimilars impact market share.
Conclusion
The imminent biosimilar competition will drive significant price decreases for adalimumab products. Short-term pricing drops will be most pronounced in the US, with ongoing reductions expected until market stabilization around 2028. Humira’s revenue will decline but remain sizable due to existing patient base and indications.
Key Takeaways
- Humira remains a top-selling biologic with $21.2 billion in 2022 sales.
- Biosimilar competition began in 2023, causing a 15–25% price reduction.
- US prices are projected to decrease to around $3,800–$4,100 per 40 mg pen by 2024.
- Total global sales are forecasted to decline 40–50% within five years.
- Market dynamics will depend on biosimilar approval, legal actions, and prescriber adoption.
FAQs
-
When will biosimilar competition significantly impact Humira’s price?
Starting in 2023, with continued market penetration over the next 2–3 years.
-
How much can prices drop in the US?
Expected decreases to $3,800–$4,100 per 40 mg pen by 2024, roughly 20–25% below current list prices.
-
Will Humira’s sales recover after patent expiry?
Sales are likely to decline but remain substantial due to ongoing indications and existing patient base.
-
What regions will see the largest price reductions?
The US will experience the steepest decline, followed by Europe as biosimilar coverage expands.
-
How does biosimilar market share impact pricing?
Increased biosimilar presence typically reduces market prices, leading to a decrease in Humira’s revenue.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] U.S. Patent and Trademark Office. (2022). Patent expiry timeline for Humira.
[3] EvaluatePharma. (2023). Biologics Price Trends.
[4] IMS Health. (2022). Biologic Market Forecast.
[5] Bernstein Research. (2023). Autoimmune & Biologic Drug Outlook.
