Last updated: March 13, 2026
What is NDC 00172-6406?
NDC 00172-6406 corresponds to a specific drug formulation under the National Drug Code (NDC) system. Based on available public data, it is identified as Humira (adalimumab), a monoclonal antibody used primarily for autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Market Overview
Product Status and Approval
Humira was original branded product by AbbVie, approved by the FDA in 2002. It remains one of the top-selling biologics globally. The product's patent protections largely expired in 2023, opening the market for biosimilars.
Biosimilar Competition
Since patent expiration, multiple biosimilars have entered the U.S. market, including:
- Amgen's Amjevita (adalimumab-atto)
- Samsung Bioepis's Hadlima (adalimumab-bwwd)
- Boehringer Ingelheim's Cyltezo
Biosimilars are priced roughly 15–30% lower than the branded Humira.
Market Share Dynamics
Initial market penetration of biosimilars has been gradual, due to:
- Physician and patient preferences
- Contracting practices favoring established brands
- Distribution agreements
As of 2023, branded Humira retains approximately 60–70% of the total adalimumab market share in the U.S., with biosimilars capturing the rest.
Geographic Market Breakdown
- North America: Dominant due to high demand and healthcare infrastructure.
- Europe: Strong biosimilar adoption.
- Asia & developing markets: Growing adoption, but slower penetration.
Pricing Trends
Historical Price Data
| Year |
Branded Humira (per syringe) |
Biosimilars (per syringe) |
| 2019 |
$2,500 |
N/A |
| 2022 |
$2,600 |
N/A (initial market entry) |
| 2023 |
$2,550 |
$1,900 - $2,200 |
Average wholesale prices reflect discounts offered through formularies and contracting.
Current Price Projection (2023–2028)
The price of branded Humira is predicted to decline steadily as biosimilar market share increases. Expected average prices:
- 2023: $2,550
- 2024: $2,400 (steady decline due to biosimilar uptake)
- 2025: $2,200
- 2026: $2,000
- 2027: $1,900
- 2028: $1,800
Biosimilars are expected to maintain prices between $1,800–$2,000 per syringe, with slight downward pressure.
Market Drivers
- Patent expiry: Clears path for biosimilar integration.
- Regulatory policies: Encouraging biosimilar substitution.
- Physician acceptance: Increasing confidence over time.
- Rebate strategies: Biosimilars offering better rebates for payers.
- Patient access: Lower costs drive higher utilization.
Key Challenges
- Resistance from legacy providers.
- Limited switching during initial rollout.
- Contracting and formulary restrictions.
- Potential legal disputes over biosimilar interchangeability.
Competitive Outlook
| Company |
Product Name |
Launch Year |
Market Share (2023) |
Pricing (Estimated) |
| AbbVie |
Humira |
2002 |
60–70% |
$2,550 |
| Amgen |
Amjevita |
2017 |
15% |
$2,000 |
| Boehringer Ingelheim |
Cyltezo |
2019 |
10% |
$1,950 |
| Samsung Bioepis |
Hadlima |
2021 |
5% |
$1,900 |
Projected market share shifts depend on payer policies and physician acceptance.
Regulatory Changes Impacting Pricing
- The FDA's approval of interchangeability standards in 2022 influences biosimilar substitution.
- State legislation on mandatory substitution varies, affecting market penetration.
- CMS policies on Medicare and Medicaid favor biosimilars, reducing utilization of branded products.
Conclusion
Humira (NDC 00172-6406) remains a significant revenue generator despite patent expiration. The biosimilar landscape introduces downward price pressure, with anticipated prices declining approximately 30–50% over the next five years. Market share shifts favor biosimilars, driven by regulatory, payer, and provider factors.
Key Takeaways
- The original branded Humira price has decreased slightly since 2022 but remains above $2,500 per syringe.
- Biosimilar entry has led to moderate market penetration, with prices around $1,900–$2,200.
- The market is expected to see continued price declines as biosimilar adoption expands.
- Regulatory policies and payer incentives will significantly influence future market dynamics.
- Competition among biosimilar manufacturers will shape pricing and market share distribution.
FAQs
-
What is the primary driver of price decline for NDC 00172-6406?
Biosimilar competition following patent expiration reduces the price of adalimumab.
-
How soon will biosimilars replace branded Humira completely?
Full market penetration could take another 5–7 years, depending on adoption rates and regulatory policies.
-
Are biosimilars approved as interchangeable with Humira?
Some biosimilars have received interchangeability designation, enabling pharmacy-level substitution in certain states.
-
What is the expected pricing trend for the next decade?
Prices are projected to decrease by approximately 10–15% annually, reaching around $1,800–$2,000 per syringe by 2028.
-
Which markets offer the highest growth potential for adalimumab products?
North America and Europe lead, but Asian markets show rapid growth, driven by increasing healthcare access and biosimilar adoption.
References
[1] U.S. Food and Drug Administration. (2022). Biosimilar and Interchangeable Products.
[2] IQVIA. (2023). Biologic Market Trends Report.
[3] EvaluatePharma. (2023). Forecasts for Biologic Drugs.
[4] American Medical Association. (2022). State Legislation on Biosimilar Substitution.
[5] Centers for Medicare & Medicaid Services. (2023). Policy on Biosimilar Utilization.
