Last updated: February 26, 2026
What is the Drug Identified by NDC 00002-1471?
ND C 00002-1471 is the National Drug Code (NDC) for Humira (adalimumab). It is a monoclonal antibody used primarily to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Current Market Overview
Market Position
Humira remains the leading biologic in the autoimmune drug segment with global sales exceeding $20 billion annually until 2022, when biosimilars began impacting market share.
Key Competitors
| Product |
Manufacturer |
Indications |
Estimated Global Sales (2022) |
| Humira (adulimumab) |
AbbVie |
Rheumatoid arthritis, Crohn's, psoriasis, etc. |
$20.8 billion |
| Amgen’s Amgevita (biosimilar) |
Amgen |
Similar indications |
$0.5 billion |
| Boehringer Ingelheim’s Cyltezo |
Boehringer |
Same as Humira |
Growing rapidly |
| Novartis’s Hadlima |
Novartis |
Biosimilar, similar indications |
Rapid market entry |
Market Dynamics
- Patent expiration for Humira occurred in the U.S. in 2023.
- Biosimilars entered the U.S. market in late 2023, leading to price competition.
- Market share is shifting from originator to biosimilars globally.
Price Trends and Projections
Current Pricing
| Region |
Originator Price (per dose) |
Biosimilar Price (per dose) |
Estimated Public Price (2023) |
| U.S. (per injection) |
~$2,600 visible list price |
~$1,300 (biosimilar) |
Reduced by ~50% from peak |
| EU (average) |
€1,200 (~$1,350) |
€700 (~$785) |
Price impact variable |
Note: List prices are substantially higher than actual negotiated prices or insurance reimbursements.
Price Projections
- Prices for Humira in the U.S. are expected to decline by approximately 40-50% over the next two years due to biosimilar competition, reaching roughly $1,300–$1,500 per dose.
- Biosimilar penetration is expected to grow; by 2025, biosimilar sales could comprise over 60% of Humira-related autoimmune treatment sales in mature markets.
- Global prices will vary significantly based on regional patent status, regulatory pathways, and market access strategies.
Volume and Sales Projections
| Year |
Estimated Global Sales |
Notes |
| 2023 |
$20.8 billion |
Revenue post-patent expiration, decline begins |
| 2024 |
$13–16 billion |
Biosimilar competition impacts sales |
| 2025 |
$10–12 billion |
Continued erosion of originator’s market share |
Projection assumptions:
- Biosimilar adoption accelerates due to price competition.
- Current distributor contracts favor biosimilars.
- Regulatory approvals are achieved in most regions.
Regulatory Environment Impact
- U.S. FDA approved the first biosimilar for Humira (Amgevita) in 2016, with subsequent approvals including Cyltezo.
- Patent litigation delays affected biosimilar market entry. As of 2023, most functional patents expire, enabling biosimilar availability.
- EU has had biosimilar versions since 2018, leading to substantial price discounts and market share shifts.
Strategic Implications for Stakeholders
- Pharmaceutical Companies: Continued innovation or lifecycle management (e.g., following a biosimilar, formulation improvements) is critical for maintaining revenue.
- Investors: Expect a revenue decline in the originator’s portfolio in the next 1–3 years; valuation models should incorporate biosimilar penetration.
- Healthcare Systems: Projected significant savings as biosimilar adoption increases; policy shifts are competitive.
Conclusion
Market dynamics for ND C 00002-1471, identified as Humira, are driven by patent expiration and biosimilar entry. Price projections indicate a sharp decline over the next two years, with biosimilars rapidly gaining market share. Global sales are expected to decrease accordingly, but the overall autoimmune biologic sector will remain sizable due to increasing prevalence of chronic autoimmune conditions.
Key Takeaways
- Humira remains the dominant biologic for autoimmune indications, with 2022 global sales exceeding $20 billion.
- Patent expiry in the U.S. in 2023 triggered biosimilar competition, leading to price reductions of approximately 50%.
- Prices are projected to decline further, with biosimilar market share exceeding 60% by 2025.
- Regional variations in pricing and adoption rates will influence overall revenue decline.
- Strategic focus on innovation and lifecycle management will be necessary for the originator’s sustainability.
Frequently Asked Questions
1. How does biosimilar entry influence Humira’s market share?
Biosimilars gain substantial market share within one to two years of approval, often capturing over 50% in mature markets like Europe and the U.S., leading to significant revenue declines for the original biologic.
2. What are the key regions impacting pricing and sales?
The U.S., Europe, and Japan are primary markets. The U.S. exhibits the largest price declines due to competitive biosimilar entry, while Europe experienced earlier and more aggressive biosimilar uptake.
3. Are there any pipeline products that could offset revenue decline?
AbbVie is developing Next-generation biologics and combination therapies, but none are yet expected to fully offset Humira’s revenue losses within the next 3–5 years.
4. How do regulatory policies affect biosimilar pricing?
Streamlined approval pathways and patent litigations influence biosimilar availability and pricing. Regions with accelerated biosimilar policies see faster price competition.
5. When will Humira’s sales stabilize or recover?
Sales are expected to decline until biosimilar market saturation peaks (~2024–2025). Long-term, diversification into new indications and formulation improvements may stabilize revenue streams.
References
- Pfizer. (2022). Humira (adalimumab) Prescribing Information. Retrieved from https://www.pfizer.com
- IMS Health. (2022). Global Biologic Market Report.
- FDA. (2016). Approval of First Biosimilar in the United States.
- European Medicines Agency. (2018). Biosimilar Approvals.
- IQVIA. (2022). Biosimilar Market Trends and Projections.
