Last updated: February 20, 2026
What is NDC 00115-1365?
NDC 00115-1365 corresponds to Humira (adalimumab) 40 mg prefilled pen. Humira is a monoclonal antibody used to treat various autoimmune conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Market Overview
Humira remains one of the top-selling biologics globally, with sales exceeding $20 billion in 2022. The drug's revenue has stabilized due to biosimilar entry in multiple markets, with significant competition from newer therapies targeting similar indications.
Market Size and Revenue Trends
| Year |
Global Humira Sales (USD billions) |
Market Share (Estimate) |
Key Competitors |
| 2022 |
20.5 |
45% |
Rinvoq, Skyrizi, Stelara, Cosentyx |
| 2021 |
21.4 |
46% |
|
| 2020 |
21.2 |
47% |
|
Source: IQVIA, 2022.
Key Market Dynamics
- Biosimilar Competition: Multiple biosimilars launched in Europe and the U.S. (e.g., Amgen's Amjevita, Samsung Bioepis' Hyrimoz) have reduced Humira's market share.
- Regulatory Approvals and Patent Expirations: The U.S. patent expired in January 2023. The penetration of biosimilars is expected to impact list prices and revenue.
- Pricing Strategy: Humira's list price has maintained high levels (~$6,000 per 40 mg prefilled syringe), but discounts and rebates are prevalent due to biosimilar competition.
Price Projections
Current Pricing (2023)
- List Price: Approximately $6,000 per 40 mg dose
- Average Net Price (after rebates): Estimated around $2,500–$3,000 per 40 mg dose
Projections for the Next 3 Years
| Year |
Estimated List Price |
Expected Market Share |
Projected Revenue (USD billions) |
| 2023 |
$6,000 |
40% |
$9.0 |
| 2024 |
$5,800 |
35% |
$6.7 |
| 2025 |
$5,600 |
30% |
$5.0 |
Assumption: List price declines of 3–4% annually driven by biosimilar market entry, with overall revenue declining accordingly.
Influencing Factors
- Biosimilar Adoption: Accelerated biosimilar penetration is likely, reducing profitability.
- Manufacturer Pricing Strategies: Intense competition may lead to significant discounts.
- Policy Changes: U.S. policies aiming to curb drug prices could further pressure list and net prices.
Competitive Landscape
| Drug Name |
Class |
Approved Indications |
Current Market Status |
| Humira (adalimumab) |
Monoclonal antibody |
RA, Crohn's, UC, Psoriasis, others |
Leading but declining share |
| Skyrizi (risankizumab) |
IL-23 inhibitor |
Crohn's, psoriasis |
Gaining market share |
| Rinvoq (upadacitinib) |
JAK inhibitor |
RA, psoriatic arthritis |
Increasing adoption |
| Stelara (ustekinumab) |
IL-12/23 inhibitor |
Crohn's, UC, psoriasis |
Sustaining significant sales |
Summary of Key Insights
- Revenue decline: Projected to decrease from $9 billion in 2023 to $5 billion by 2025.
- Price erosion: List prices expected to decline 3-4% annually owing to market expansion of biosimilars.
- Market share shifts: Biosimilar entry will cut Humira’s share, though durable demand in certain indications sustains revenue.
- Competitive threats: Emerging alternatives and regulatory pressures influence pricing strategies and market share.
Key Takeaways
- Humira faces declining revenue due to biosimilar competition, impacting list prices and market share.
- The drug's revenue is projected to decrease approximately 50% over the next three years.
- Price reductions are expected annually, driven by biosimilar market penetration and policy shifts.
- Competition from newer biologics and oral therapies will influence long-term market dynamics.
- Market positioning will depend on manufacturer strategies, pricing flexibility, and regulatory landscape.
FAQs
1. How will biosimilar entry affect Humira's pricing?
Biosimilar entry typically prompts list price reductions of 20–40%, coupled with increased discounts and rebates, decreasing net revenue.
2. What are the main factors influencing Humira’s revenue decline?
Biosimilar competition, patent expiry, shifting physician preferences, and payer negotiations.
3. Are all indications equally impacted?
Yes. While some indications maintain higher demand, overall revenue declines across all approved uses due to shares shifting to biosimilars.
4. Which competitors are most threatening to Humira?
Skyrizi, Rinvoq, Stelara, and biosimilars from major manufacturers are the primary threats.
5. Could regulatory policies slow revenue decline?
Yes. Price caps, formulary restrictions, or import policies could further pressure pricing and sales.
References
- IQVIA, 2022. Pharmaceutical Market Data.
- FDA, 2023. Humira (adalimumab) approval documents.
- EvaluatePharma, 2022. Biologic Market Forecast.
- MedTech Insights, 2023. Biosimilar Trends in US and EU.
- U.S. Patent and Trademark Office, 2023. Patent expiration data for Humira.
