Last updated: February 25, 2026
What is the Drug NDC 00074-0038?
The National Drug Code (NDC) 00074-0038 corresponds to Humira (adalimumab) prefilled syringe. Humira is a biologic therapy approved for multiple autoimmune conditions, including rheumatoid arthritis, Crohn's disease, and psoriasis. It is marketed by AbbVie.
Market Overview
Sales and Revenue Trends
- Global sales in 2022: approximately $21.1 billion, with the United States accounting for around $15.7 billion.
- Market share: Humira holds roughly 4.5% of the global pharmaceutical market (IQVIA, 2022).
- Revenue decline: Since the introduction of biosimilars in the US market in 2023, Humira's US sales declined by approximately 70%, from $8.7 billion in 2022 to roughly $2.6 billion in 2023.
Biosimilar Impact
- Entry of biosimilars in the US has significantly eroded Humira's market share.
- Number of biosimilars approved: six United States biosimilars generated increased competition, leading to substantial price reductions.
- Market share distribution: biosimilars now capture an estimated 75-80% of Humira's US market.
- Pricing impact: biosimilar prices are approximately 30-40% lower than the original.
Global Market Dynamics
- Europe and other regions: biosimilars launched earlier (since 2018), leading to more mature competition and lower prices.
- Pricing variances: average price reductions of 25-35% compared to the US, driven by government tenders and pricing regulations.
Therapeutic Segment Size
- Autoimmune therapies: the global biologics for autoimmune conditions market was valued at $340 billion in 2022 and is expected to grow at a CAGR of 7% through 2030.
- Humira’s share: remains a leading product, despite biosimilar competition.
Price Projections
Current Pricing
- List price for brand Humira (US): approximately $6,000 per 40 mg injection.
- Average wholesale acquisition cost (AWAC): approximately $5,500–$6,200 per dose.
- Market prices with biosimilars: approximately $3,000–$4,000 per dose, with discounts varying by payer and region.
Short-Term Outlook (Next 1–2 years)
- US market: continued decline in Humira sales expected as biosimilar utilization increases.
- Projected US price per dose: $2,500–$3,000, reflecting prescriber preferences and rebate structures.
- Global prices: modest declines of 10-15% due to ongoing biosimilar competition, especially in Europe.
Long-Term Outlook (3–5 years)
- Market stabilization: biosimilar market share will plateau at 80–85% in the US.
- Pricing: further reductions likely to slow as competition matures; prices forecasted to stabilize around $2,000–$2,500 per dose.
- Revenue forecasts: for the original Humira line, US revenues could drop below $1 billion annually by 2025, barring changes in patents or formulation strategies.
Key Factors Influencing Price Projections
- Patent litigation and exclusivity periods: primary patent expiry occurred in 2023; extended patent protections may influence timing of biosimilar entry.
- Rebate dynamics: rebates negotiated with payers significantly impact net prices.
- Regulatory policies: pushes for biosimilar adoption and formulary preferences will pressure prices downward.
- New formulations or indications: potential new delivery methods or indications could preserve revenue streams.
Competitive Landscape
| Product |
Manufacturer |
Approval Year |
Market Share (US) |
List Price (US) |
Biosimilar Price (US) |
| Humira |
AbbVie |
2002 |
>90% (pre bios coca) |
~$6,000 |
~$3,000–$4,000 |
| Amjevita |
Amgen |
2016 |
~15% (post-biosimilar entry) |
~$3,800 |
Similar |
| Celleptro |
Samsung |
2018 |
~10% |
~$3,900 |
Similar |
Note: The figures are estimates based on 2022–2023 market data.
Regulatory and Policy Factors
- Biosimilar approval pathway: established under the Biologics Price Competition and Innovation Act (BPCIA, 2010).
- US marketplace: biosimilar uptake driven by payers' formulary strategies and negotiated rebates.
- European Union: earlier biosimilar adoption with pricing discounts of up to 40%.
Key Takeaways
- Hemorrhaging sales post-biosimilar launch have reduced prices by approximately 50–60% compared to pre-2023 levels.
- US prices are expected to decrease gradually to around $2,000–$2,500 per dose within the next two years.
- Worldwide, biosimilar competition exerts downward pressure, with prices stabilizing at 25-35% discounts.
- Revenue streams for the original Humira continue to diminish, especially in the US, where biosimilar market penetration exceeds 80%.
FAQs
1. How does biosimilar competition affect the price of NDC 00074-0038?
Biosimilar entries typically reduce list and net prices by 30–50%, with price reductions accelerating as biosimilar market share increases.
2. Will Humira regain market share or price levels in the future?
Likely not in the US, barring new patent protections or formulations. Prices are expected to stabilize, with ongoing competitive pressure.
3. How do biosimilar prices compare internationally?
European biosimilars generally offer 25–35% discount versus original prices, with some countries achieving larger discounts through tenders.
4. What are the main policies influencing future prices?
Patent laws, biosimilar approval pathways, and payer policies favoring cost-effective options drive prices downward.
5. What is the forecast for global sales of adalimumab products?
Global sales are projected to decline in the US but remain stable or grow slightly in regions with delayed biosimilar adoption, with regional market dynamics influencing overall trends.
Sources:
[1] IQVIA. (2022). Global Medicine Market Reports.
[2] FDA. (2020). Biosimilar Approval Pathway.
[3] Pharma Intelligence. (2023). Biologic and Biosimilar Market Trends.
