Last updated: February 21, 2026
What Is the Drug Represented by NDC 00480-9733?
NDC 00480-9733 corresponds to Humira (adalimumab), a monoclonal antibody developed by AbbVie. It is used in the treatment of multiple autoimmune conditions, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Market Size and Demand for Humira
Humira remains one of the best-selling drugs worldwide, with total global revenue reaching $20.5 billion in 2022, according to AbbVie’s financial disclosures. Despite the genericization of some biosimilars, it maintains a significant market share due to its broad approval scope and established usage patterns.
Key Market Drivers
- Expansion of indications
- Increasing prevalence of autoimmune diseases
- Patent expiry effects
- Biosimilar competition
Market Segments
- Rheumatoid arthritis: Largest segment, approximately 40% of sales.
- Crohn’s disease: 20%
- Psoriasis: 15%
- Ulcerative colitis: 10%
- Other indications (ankylosing spondylitis, hidradenitis suppurativa): 15%
Patent and Biosimilar Landscape
- The original patent expired in the U.S. in 2016.
- Biosimilars launched in the U.S. in 2023, notably Amgen's Amjevita and Samsung Bioepis’ Hadlima.
- Patent protections continue in certain jurisdictions until 2030, limiting biosimilar penetration outside the U.S.
Biosimilar Impact
- Volume share of biosimilars in the U.S. reached 20% in 2022.
- Price reductions for biosimilars are typically 15-25% relative to the originator, but price competition varies by market.
Price Trends and Projection
Historical Pricing
- The wholesale acquisition cost (WAC) for Humira in the U.S. was approximately $6,600 per month per 40 mg pen or syringe in 2022.
- Post-biosimilar entry, prices have declined to approximately $4,500–$5,000.
Current and Projected Pricing Trajectory
| Year |
Estimated Average Wholesale Price (U.S.) |
Notes |
| 2022 |
$6,600/month |
Pre-biosimilar launch |
| 2023 |
$5,000/month |
Biosimilar entry begins |
| 2024 |
$4,500/month |
Biosimilar market expands |
| 2025 |
$4,200/month |
Further biosimilar competition |
| 2026 |
$4,000/month |
Stabilization at lower price point |
Future Considerations
- The proportion of biosimilar prescriptions will increase, further exerting downward pressure.
- Price erosion could plateau around $3,500–$4,000 per month by 2028 if biosimilar adoption accelerates globally.
- Price bargaining with payers could reduce net costs further, especially with managed care interventions.
Revenue Forecasting
- Assuming a 40-50% market share for Humira (and biosimilars) in the autoimmune segment, with revenue estimates consistent with historical figures, revenues could decline from $20.5 billion (2022) to approximately $12-14 billion by 2028.
- Revenue impact varies by geography, heavily influenced by biosimilar uptake and pricing strategies.
Competitive Landscape
| Competitors |
Market share |
Key Features |
| Amgen (Amjevita) |
Growing |
Approved in multiple regions, similar efficacy |
| Samsung Bioepis (Hadlima) |
Growing |
Competitive pricing, widespread availability |
| Innovator (Humira) |
Declining |
Limited patent protections in certain areas |
Biosimilars are gaining momentum in the U.S. and Europe, with other markets following. Pricing pressure will intensify as biosimilars expand their prescriptive share.
Key Factors Affecting Future Prices
- Regulatory approvals in additional countries
- Payer negotiations and formulary placements
- Biosimilar market entry timing and local adoption rates
- Policy shifts toward biosimilar promotion
Summary
Humira (NDC: 00480-9733) remains a dominant player in autoimmune therapeutics but faces decline due to biosimilar competition. Price reductions are ongoing, with projections indicating a continued downward trend through 2028. Market share shifts and payer strategies will influence revenue trajectories and market dynamics.
Key Takeaways
- Humira's global revenue was $20.5 billion in 2022; biosimilar competition is reducing prices.
- U.S. prices have dropped from approximately $6,600/month before biosimilar entry in 2022 to around $4,500–$5,000.
- Biosimilar market penetration is expected to grow, further compressing prices.
- Revenue forecasts for Humira suggest a decline to $12–14 billion by 2028.
- Price pressure largely depends on biosimilar adoption rates and regional regulatory policies.
FAQs
1. How much has the price of Humira decreased since biosimilar entry?
Prices have decreased from around $6,600/month in 2022 to approximately $4,500–$5,000/month in 2023.
2. What are the main biosimilars competing with Humira?
Amgen’s Amjevita and Samsung Bioepis’ Hadlima are the leading biosimilars.
3. When are biosimilars expected to significantly impact Humira’s revenue?
Biosimilar prescription share is projected to reach 50% by 2025, with corresponding revenue declines expected from 2024 onward.
4. How does regional regulation influence price projections?
Regions with delayed biosimilar approvals or stricter patent protections may sustain higher prices longer. Conversely, faster biosimilar adoption in certain markets accelerates price declines.
5. What factors could alter the current price projection outlook?
Regulatory changes, patent disputes, payer negotiations, and new indications could influence the pace and extent of price reductions.
References
- AbbVie. (2022). Humira (adalimumab) global sales report. [Company Financials].
- IQVIA. (2022). Global Immunology Market Data.
- U.S. Food and Drug Administration. (2023). Biosimilar approvals and patent timeline.
- NICE. (2022). Cost-effectiveness and biosimilar policies.
- EvaluatePharma. (2022). 2022 Top Selling Drugs.
