Last updated: February 26, 2026
What is NDC 00378-8078?
NDC 00378-8078 corresponds to Humira (adalimumab) injection, used to treat autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and psoriasis. It is manufactured by AbbVie. Humira remains one of the best-selling pharmaceuticals globally, with significant market penetration since its launch.
Market Size and Dynamics
Global Sales Overview
Humira generated approximately $21.2 billion in revenue in 2022, representing a slight decline from its peak of $20.9 billion in 2021, owing to patent expirations and biosimilar competition in various markets [1].
Key Markets
- United States: Largest market, accounting for roughly 60% of global sales.
- Europe: Significant but declining following biosimilar launches; sales totaled around $4.5 billion in 2022.
- Rest of the World: Emerging markets expanding, though with lower per capita spending.
Patent Expiry and Biosimilar Entry
- The U.S. patent protection for Humira expired in January 2023.
- Several biosimilars launched in late 2023, including Amgevita (Amgen/Samsung), Cyltezo (Boehringer-Ingelheim), and Hadlima (Samsung/MJN).
- Biosimilar penetration in the U.S. is expected to reach 70-80% of Humira’s volume within 2 years, pressuring pricing.
Regulatory Environment
- The FDA approved multiple biosimilars for Humira in 2023.
- Pricing strategies include preferred formulary positioning and discounting to maintain market share.
Price Projections
Direct Competition Impact
- Average U.S. list price for Humira: approximately $6,000 per 40 mg pen or syringe before discounts or rebates [2].
- Biosimilars are priced at an average 15-25% discount compared to the original biologic.
- Net prices after rebates are generally 60-70% of the list price, reducing per-unit revenue.
Price Trend Forecasts
| Year |
Humira List Price (U.S.) |
Biosimilar Average Price |
Expected Market Share (Humira vs. Biosimilar) |
| 2023 |
$6,000 |
$4,500 |
50% (Humira), 50% (biosimilars) |
| 2024 |
$5,900 |
$4,400 |
30% (Humira), 70% (biosimilars) |
| 2025 |
$5,800 |
$4,300 |
15% (Humira), 85% (biosimilars) |
| 2026 |
$5,700 |
$4,200 |
10% (Humira), 90% (biosimilars) |
Price erosion driven by biosimilar competition could decline net revenue per dose by approximately 25-30% over the next 2-3 years in the U.S., with global impacts depending on regional biosimilar adoption.
2023-2026 Revenue Forecast
- 2023: $20.4 billion (approximate, considering biosimilar entry)
- 2024: $17.4 billion
- 2025: $14.7 billion
- 2026: $12.4 billion
Price Projections Summary
- List prices will likely decline modestly, averaging a 2-3% annual decrease.
- Net price adjustments will be more pronounced due to rebates, especially in competitive markets.
- Overall, revenue will diminish unless growth factors such as new indications or formulations are realized.
Key Factors Influencing Future Market and Pricing
1. Biosimilar Adoption: Rapid uptake in the U.S. and Europe will exert sustained pressure on prices.
2. Patent Litigation and Market Exclusivity: Ongoing patent disputes may delay biosimilar entry in certain regions, temporarily stabilizing prices.
3. Formulation Innovations: Potential for new delivery methods or indications could revive growth.
4. Contracting Strategies: AbbVie may employ rebate strategies and exclusive contracts to retain market share amid biosimilar competition.
5. Regulatory Changes: Price control policies in various countries could cap prices or restrict reimbursement levels.
Key Takeaways
- Humira (NDC 00378-8078) remains a high-revenue drug, but patent expiry and biosimilar competition will heavily influence market share and prices.
- U.S. biosimilar penetration is projected to reach 70-80% within two years, reducing average net prices.
- Pricing will decline by approximately 2-3% annually, with net revenue declining faster due to rebates and discounts.
- Revenue forecasts indicate a downward trend from $20.4 billion in 2023 to around $12.4 billion in 2026 unless new indications or formulations are introduced.
FAQs
-
When will biosimilar competition fully impact Humira’s U.S. sales?
Biosimilars are expected to constitute over 70% of the U.S. market volume by late 2024.
-
How much will prices decrease due to biosimilar entry?
List prices are expected to decline by 15-20%, with net prices decreasing by roughly 25-30% over two years.
-
What factors could reverse or slow the decline in revenue?
Introduction of new formulations, additional indications, or delayed biosimilar market penetration.
-
Are biosimilar prices consistent globally?
No. Developed markets like Europe typically see higher biosimilar adoption and steeper price declines than emerging markets.
-
What strategies does AbbVie employ to maintain market share?
Rebate strategies, formulary negotiations, and expanding indications aim to offset biosimilar pricing pressure.
References
[1] IQVIA. (2023). Global Medicine Spending and Usage Report 2022.
[2] GoodRx. (2023). Humira (adalimumab) Prices and Costs.
