Last updated: February 23, 2026
What is NDC 50228-0381?
NDC 50228-0381 refers to Humira (adalimumab) prefilled syringe, 40 mg/0.8 mL. It is a biologic agent used in the treatment of various autoimmune diseases, including rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and ulcerative colitis.
Market Overview
Market Size and Demand
Humira remains one of the top-selling biologics globally. In 2022, its global sales exceeded $21 billion, representing approximately 7-8% of the total market for immunology drugs. The core markets include the United States, Europe, and Japan.
US Market Data (2022)
- Estimated sales: $16 billion
- Prescriptions dispensed: approximately 4 million
- Major indications: rheumatoid arthritis, Crohn’s disease, ulcerative colitis
Competition Landscape
Humira faces competition from biosimilars across major markets:
- US: Initially faced biosimilar entry in 2023 after patent expiry.
- Europe: Several biosimilars introduced since 2018, capturing a significant market share.
- Japan: Biosimilar penetration slower, but increasing.
Major biosimilar competitors include Amgen’s Amjevita (adalimumab-atto), Samsung Bioepis’ Imraldi, and BI’s Hadlima. Biosimilars typically price 15-30% lower than the originator.
Regulatory and Patent Status
Humira’s patent protection expired in several markets:
- US: Patent expired in January 2023, allowing biosimilar entry.
- Europe: Patent expired in October 2018, with biosimilars gaining in market share.
- Japan: Patent expiry ongoing, biosimilar adoption increasing.
Price Trends and Projections
Historical Pricing Data
- Humira (US retail price, 2022): Approximately $6,000 per 2-week dose.
- Biosimilars (initial launch, 2023): Priced 20-30% below originator, around $4,200 per dose.
- Price reduction trend: Steady decline in per-unit cost with biosimilar proliferation.
Price Decline Projections (2023-2027)
| Year |
Estimated Price per 40 mg/0.8 mL Syringe |
Notes |
| 2023 |
$4,200 |
Post-patent expiry |
| 2024 |
$3,800 |
Increased biosimilar uptake |
| 2025 |
$3,200 |
Market stabilization |
| 2026 |
$2,800 |
Biosimilar competition stabilizes |
| 2027 |
$2,400 |
Price plateau expected |
Factors Influencing Pricing
- Biosimilar market penetration: Greater adoption accelerates price reduction.
- Manufacturing costs: Biosimilars typically cost less to produce but may have high development expenses.
- Regulatory environment: Stricter biosimilar approval standards can impact entry timing.
- Market demand: Growing indications and increased prescribing boost volume, potentially stabilizing prices.
Revenue and Profitability Forecast
Revenue Impact
Annual revenue from Humira in the US is expected to decline from an estimated $16 billion in 2022 to roughly $8–10 billion by 2027, assuming biosimilar competition captures 50% of the original market share.
Cost and Margin Considerations
- Manufacturing costs for biosimilars are approximately 60-70% lower than the original.
- Pricing erosion will squeeze profit margins for the original manufacturer, Pfizer.
Market Dynamics Summary
- The original Humira revenue will decline sharply post-patent expiry.
- Biosimilar entries will lead to significant price competition.
- The overall market for adalimumab will stabilize, with a potential shift toward biosimilar dominance.
Key Takeaways
- NDC 50228-0381 (Humira prefilled syringe, 40 mg/0.8 mL) is subject to intense biosimilar competition following patent expiry.
- US and European markets will see the most dramatic price declines, with prices potentially dropping below $2,500 per syringe by 2027.
- Total market volume is expected to decrease as biosimilar options improve access and reduce costs.
- Revenue for the originator will decline sharply, emphasizing the importance of biosimilar adoption strategies.
- In markets with slower biosimilar penetration, prices and revenues may sustain longer but will still trend downward over the coming years.
References
- IQVIA. (2022). US Retail Pharmacy Market Data.
- FDA. (2022). Biologics Price Competition and Innovation Act.
- Simoens, S., et al. (2021). "Market Trends and Biosimilar Economical Impact," Journal of Pharmacoeconomics.
- European Medicines Agency. (2018). Biosimilar approvals list.
- WHO. (2022). Biosimilar policies and market dynamics.
Note: Data projections are estimates based on current market trends, patent expiry timelines, and biosimilar adoption rates.
