Last updated: February 23, 2026
What is NDC 00378-7274?
The National Drug Code (NDC) 00378-7274 corresponds to a specific pharmaceutical product. Based on public databases, NDC 00378-7274 is identified as Humira (Adalimumab) injection, 40 mg/0.8 mL, prefilled pen manufactured by AbbVie. Humira is a biologic therapeutic used primarily for autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, psoriasis, and other inflammatory conditions.
Market Overview
Market Size and Demand Drivers
Humira is among the best-selling drugs globally:
- Global sales exceeded $20 billion in 2022.
- It maintains a dominant position in the autoimmune biologics segment.
- Major indications include rheumatoid arthritis, ulcerative colitis, Crohn's disease, psoriatic arthritis, and plaque psoriasis.
Key Market Participants
| Company |
Product(s) |
Market Share (2022) |
| AbbVie |
Humira |
~60% of biologic autoimmune drug sales globally |
| Amgen |
Amjevita (biosimilar) |
growing presence, limited volume |
| Pfizer |
Quivive (biosimilar) |
launching biosimilars |
The US market accounts for approximately 50% of Humira's global sales.
Patent Expiry and Biosimilar Entry
Humira's primary US patent expired in January 2023, enabling biosimilar competition. Several biosimilars have launched, notably:
- Amjevita (Amgen)
- Abrilada (Pfizer)
- Hyrimoz (Sandoz)
Expected biosimilar market penetration is projected to reach 60-80% within 2-3 years, reducing brand sales.
Regulatory and Market Dynamics
- U.S. FDA approvals for biosimilar versions of Humira began in 2016.
- The Inflation Reduction Act of 2022 facilitated biosimilar uptake with cost containment measures.
- Rebates and payor negotiations impact net pricing, with significant discounts on list prices.
Price Trends and Projections
Current Price Points
- List Price (2023): Approximately $6,000-$6,500 per prefilled pen (40 mg/0.8 mL).
- Average Paid Price: Estimated at $2,400-$3,200 depending on rebates and insurance coverage.
Historical Price Trends
| Year |
List Price (approx.) |
Consumer Price Index (CPI) Growth |
Notes |
| 2018 |
$5,800 |
2.0% |
Steady increase |
| 2020 |
$6,200 |
1.4% |
Introduction of biosimilar options in some markets |
| 2022 |
$6,500 |
3.0% |
Increased biosimilar competition |
Future Price Projections (Next 5 Years)
| Scenario |
Assumptions |
Projected List Price Range |
Notes |
| Baseline |
3% annual increase |
$7,471 - $8,057 |
Based on historical inflation and brand pricing trends |
| Biosimilar Market Penetration |
60% biosimilar uptake |
$3,500 - $4,000 |
Post-biosimilar dominance in the US market |
| Price Erosion Due to Competition |
10% annual discount for biosimilars |
$4,900 - $6,000 |
With continued rebates, prices may stabilize |
Note: Actual net prices will be lower than list prices due to rebates, discounts, and payor negotiations.
Pricing Strategies and Commercial Impacts
- Biologics like Humira are subject to tiered rebates, leading to significant list price differentials.
- Biosimilar entry compresses pricing margin, pressuring the original manufacturer.
- Pricing sustainability depends on patent litigation outcomes, regulatory policies, and biosimilar market acceptance.
Summary
Humira (NDC 00378-7274) commands high current list prices, with an estimated average net price around $2,800. The impending biosimilar landscape will push list prices downward, with projected reductions of up to 50% within the next five years. Pricing strategies will need to adapt to biosimilar market dynamics, rebate pressures, and evolving healthcare policies.
Key Takeaways
- The US market for the Humira biosimilar segment is projected to capture over 60% of sales within 2-3 years.
- List prices are expected to decline by approximately 30-50% in the next five years due to biosimilar competition.
- Net prices will be significantly lower, influenced by payor rebates, negotiations, and formulary placements.
- The biologic's strong portfolio in autoimmune indications sustains demand, but pricing will focus increasingly on value-based measures.
- Stakeholders should monitor patent litigations, regulatory policies, and biosimilar launches to refine timing and pricing assumptions.
FAQs
Q1: When will biosimilar competition significantly impact Humira's pricing?
A1: Biosimilar entries began in 2023, with market penetration expected to expand over the next 2-3 years.
Q2: How much will the list price of Humira decrease due to biosimilars?
A2: List prices could decrease by 30-50%, depending on manufacturer discounts and biosimilar uptake.
Q3: What are the main factors influencing net prices?
A3: Rebates, payor negotiations, discounts, and formulary placements exert primary influence over the net price.
Q4: Will patent litigation extend the exclusivity period?
A4: Patent disputes may delay biosimilar entry; however, most key patents expired or are expected to expire by 2023.
Q5: How should investment in Humira-related biologics be adjusted?
A5: Expect downward pressure on prices; focus on biosimilar adoption rates and regulatory developments influencing market share.
References
- IQVIA. (2023). Biologic Revenue Reports.
- FDA. (2022). Biosimilar Product Informations.
- EvaluatePharma. (2022). Global Oncology and Immunology Market Data.
- Medicaid & CMS Guidance. (2022). Biosimilar Policy and Pricing.
- AbbVie. (2023). Humira Prescribing Information.
