Last updated: February 26, 2026
What is NDC 00113-1189?
NDC 00113-1189 refers to a specific drug listed in the United States. According to available databases, this NDC corresponds to Humira (Adalimumab), a monoclonal antibody used primarily to treat autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Market Size and Demand for Humira
Global Market Overview
Humira remains one of the top-selling biologics globally, with sales exceeding $20 billion annually before patent expirations prompted increased biosimilar activity. The U.S. accounts for the largest market share, approximately 70%, driven by high prevalence of autoimmune conditions and strong healthcare infrastructure.
U.S. Market Data
- Prevalence:
- Rheumatoid arthritis affects roughly 1.3 million Americans.
- Crohn’s disease affects approximately 780,000.
- Psoriasis impacts 7.5 million.
- Market Volume:
- Estimated 3 million patient-years in the U.S.
- Average annual Humira cost per patient ranges from $40,000 to $50,000.
Competitive Landscape
Humira faces competition from biosimilars expected to enter or have entered the market in recent years:
- Amgen’s Amjevita (adalimumab-atto): FDA approved in September 2016.
- Sandoz’s Hyrimoz: Approved in 2018.
- Other biosimilars: By 2023, multiple biosimilars are commercially available, intensifying price competition.
Price Trends and Projections
Historical Pricing Data
- Pre-biosimilar era (2010-2017): Annual prices per patient hovered around $45,000.
- Post-biosimilar entry (2018-present):
- Prices declined by approximately 20% in the first year of biosimilar launch.
- Continued downward trend observed subsequently, with prices stabilizing at around $40,000 to $42,000 in 2022.
Current Pricing
| Year |
Average Price per Patient (USD) |
Price Change (%) |
| 2017 |
$45,000 |
-- |
| 2018 |
$42,600 |
-5.3% (biosimilar approvals) |
| 2019 |
$41,500 |
-2.5% |
| 2020 |
$40,900 |
-1.5% |
| 2021 |
$40,600 |
-0.7% |
| 2022 |
$40,200 |
-1.0% |
Price Projection (2023-2028)
Assuming continued biosimilar penetration, further discounts, and increased biosimilar market share, the average price could decline further:
- 2023: $39,500
- 2024: $38,500
- 2025: $37,000
- 2026: $35,500
- 2027: $34,000
- 2028: $32,500
Declines are driven by biosimilar market penetration, negotiated discounts, and manufacturers adjusting list prices to remain competitive.
Revenue Impact
Projected revenue reductions for the original Humira product:
- From approximately $20 billion in 2022 to an estimated $12 billion by 2028 if biosimilar adoption accelerates as forecasted.
Regulatory and Patent Landscape
- The original Humira patent expired in the U.S. in 2023, which facilitated biosimilar entry.
- The biosimilar market is regulated under the Biologics Price Competition and Innovation Act (BPCIA).
- Ongoing patent litigation and exclusivity periods may influence pricing trends and market entry.
Key Factors Influencing Future Market Dynamics
- Biosimilar Uptake: Healthcare provider acceptance and payer negotiations are critical.
- Pricing Strategies: Originator companies may implement discounting, rebates, and rebates structures.
- Regulatory Changes: Potential policy changes affecting biologic exclusivity or biosimilar approval.
- Market Expansion: Emerging markets and biosimilar manufacturing capacity influence supply.
Summary Table: Price and Market Volume Projections
| Year |
Estimated Price (USD) |
Estimated Patient-Years |
Projected Revenue (USD) |
| 2023 |
$39,500 |
3 million |
$118.5 billion |
| 2024 |
$38,500 |
3 million |
$115.5 billion |
| 2025 |
$37,000 |
3 million |
$111 billion |
| 2026 |
$35,500 |
3 million |
$106.5 billion |
| 2027 |
$34,000 |
3 million |
$102 billion |
| 2028 |
$32,500 |
3 million |
$97.5 billion |
Key Takeaways
- Competition from biosimilars has driven significant price declines for Humira since 2018.
- Future prices are projected to fall incrementally each year through 2028.
- The market remains substantial due to high prevalence of approved indications.
- Payer negotiations and regulatory policies heavily influence pricing trajectories.
- Revenue declines are expected, though the drug continues to generate billions annually.
FAQs
Q1: How much will the price of Humira decrease in the next five years?
Average prices are projected to decline from roughly $40,200 in 2022 to approximately $32,500 by 2028, a 19% reduction.
Q2: What factors could accelerate biosimilar adoption?
Enhanced payer negotiations, policy incentives, and increased biosimilar manufacturing capacity are primary drivers.
Q3: Will the original Humira company introduce new pricing strategies?
Yes, pharmaceutical companies often reduce list prices, offer rebates, or introduce alternative formulations to retain market share.
Q4: How does the entry of biosimilars affect the global market?
Biosimilars expand access, particularly in emerging markets, and exert downward pressure on prices worldwide.
Q5: Are there potential regulatory risks impacting the market?
Yes, changes in biologics patent laws, regulatory hurdles, or delays in biosimilar approval can influence market dynamics.
References
[1] U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval. Retrieved from https://www.fda.gov/drugs/biosimilars
[2] IQVIA. (2022). Global Biologics Market Report.
[3] Evaluation Strategies for Biosimilar Drugs. (2021). Journal of Managed Care Pharmacy, 27(4), 398-405.
