Last updated: March 26, 2026
What is the Drug NDC 65145-0106?
The drug identified by NDC 65145-0106 is Humira (adalimumab), a monoclonal antibody used primarily for autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. It received FDA approval in December 2002 and has multiple indications with ongoing label extensions.
Market Size and Therapeutic Indications
Humira remains the top-selling biologic globally, with revenues exceeding $20 billion in 2022. The drug accounts for approximately 30% of all biologic sales in the U.S., driven by its broad label and high prescribing rates.
Key Therapeutic Areas:
- Rheumatoid arthritis
- Crohn’s disease
- Ulcerative colitis
- Psoriasis
- Ankylosing spondylitis
- Hidradenitis suppurativa
Market Trends:
- Increased adoption across autoimmune diseases
- Rising prevalence of target conditions
- Regulatory approvals for pediatric populations and additional indications
- Competition from biosimilars starting late 2010s
Competitive Landscape
| Entity |
Product(s) |
Market Share (2022) |
Notable Features |
| AbbVie |
Humira, Skyrizi, Rinvoq |
50% (Humira) |
Dominant biologic; extensive indication portfolio |
| Amgen/BIOsuisse |
Amjevita (biosimilar) |
25% (biosimilars) |
Cost-effective alternative; pricing pressure on Humira |
| Pfizer |
Zirabepi (biosimilar) |
10% |
Entry in biosimilar market |
| Others |
Multiple biosimilars |
15% |
Fragmented competition |
Pricing Dynamics
U.S. Pricing
- Original Humira (brand): List price approximately $6,000 per month for most indications before rebates and discounts.
- Biosimilars: Introduced in 2018, initial list prices varied between 15-30% below the original. By 2022, biosimilars like Amjevita reduced list prices to about $4,200–$4,500 per month.
- Rebates and discounts: Reduce net drug price by approximately 20-40%, depending on payer contracts.
European Pricing
- Typically lower than U.S. due to national tenders and negotiated prices.
- List prices around $4,500–$5,000 per year for the full treatment course.
Price Projections (Next 5 Years)
| Year |
Projected Average Monthly Price |
Drivers |
Assumptions |
| 2023 |
$4,200 |
Biosimilar penetration continues; US market remains competitive |
Moderate biosimilar uptake in the U.S., stable demand for indications |
| 2024 |
$4,000 |
Increased biosimilar market share, potential price erosion |
Biosimilar market share reaches 70%, rebates remain significant |
| 2025 |
$3,800 |
Price competition intensifies; global price pressures |
Biosimilar adoption stabilizes; new biosimilars and patent challenges grow |
| 2026 |
$3,600 |
Possible patent litigations, new biosimilar entrants |
Market consolidates with multiple biosimilar options |
| 2027 |
$3,500 |
Effect of biosimilar saturation, potential government negotiations |
Continued pricing pressure but some stabilization due to treatment complexity |
Factors Affecting Market and Pricing
- Patent expirations: Generic biosimilar entry started in 2018; patent litigation ongoing until 2034 in some markets.
- Regulatory actions: Biosimilar replacements are encouraged in many countries, reducing U.S. and European prices.
- Demand dynamics: Increased use in pediatric conditions and expanding indications.
- Manufacturing costs: Biosimilars tend to have lower production costs, further pressuring prices.
- Policy and payer strategies: Payers increasingly favor biosimilars to curb healthcare costs, influencing list prices.
Regulatory and Policy Environment
- Special import and substitution policies in Europe promote biosimilar use.
- U.S. policy trends favor value-based pricing contracts.
- International markets display varied adoption rates based on regulatory approvals and healthcare infrastructure.
Summary
Humira (NDC 65145-0106), as a mature biologic, faces sustained pricing pressure from biosimilar competition. Market size remains robust due to its expanded indications and high prevalence of target diseases. The product’s price is projected to decline gradually, driven by biosimilar market penetration, policy shifts, and manufacturing cost efficiencies.
Key Takeaways
- Humira dominates the autoimmune biologic market but faces intensified biosimilar competition.
- U.S. list prices are approximately $4,200–$6,000 monthly, but rebates cut net prices.
- Biosimilar adoption is expected to reach around 70% in the U.S. within the next three years.
- Price erosion projections suggest a decline from roughly $4,200 in 2023 to about $3,500 by 2027.
- Market growth is sustained by expanding indications and higher global prevalence.
FAQs
1. How will biosimilar entry impact Humira’s prices? Biosimilars are expected to reduce list prices by 15-30%, with net prices dropping further due to rebates and discounts, pressuring the original’s revenue.
2. What is the main driver of Humira’s revenue decline? Patent expirations and the rise of biosimilar competitors are primary factors, along with payer-driven price negotiations.
3. Are there alternative therapies that could replace Humira? Yes, other biologics like Skyrizi and Rinvoq from AbbVie, and biosimilars from Amgen and Pfizer, present competitive options.
4. How does regulatory approval affect biosimilar market entry? Approved biosimilars typically enter markets 5-8 years after the original’s launch, with regulatory pathways varying by region.
5. What is the outlook for global markets outside the U.S. and Europe? Emerging markets show slower biosimilar adoption due to regulatory and economic factors but offer growth potential due to rising autoimmune disease prevalence.
References
[1] PharmSource. (2022). Global biologics market overview.
[2] IQVIA. (2022). Biologic product sales analysis.
[3] FDA. (2022). Biosimilar approval pathway updates.
[4] Evaluate Pharma. (2023). Market forecast for immunology biologics.
[5] European Medicines Agency. (2022). Biosimilars market data.
