Last updated: February 23, 2026
What is NDC 69367-0307?
NDC 69367-0307 is a drug identified as Humira (adalimumab) for subcutaneous injection. It is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, psoriasis, and ulcerative colitis. The drug is produced by AbbVie.
Market Overview
Market Size
Humira is among the top-selling biologics globally. In 2022, it generated approximately $21.3 billion in sales, accounting for roughly 9% of global biosimilar and biologic markets (source: IQVIA). U.S. sales totaled approximately $13.5 billion, making it the highest revenue-generating biologic in the country.
Competitor Landscape
Humira's main competitors include:
- Amgen's Amjevita (adalimumab-atto): Approved in 2016, biosimilar with similar efficacy.
- Sandoz's Hyrimoz (adalimumab--): Approved in 2018.
- Boehringer Ingelheim's Cyltezo: Approved in 2017.
- AbbVie's own higher-dose formulations and formulations with modified delivery devices.
Patent and Legal Landscape
Humira's patent exclusivity in the U.S. extended until January 2023. Following patent expiry, biosimilar competition rapidly increased. Multiple biosimilars entered the U.S. market in 2023, leading to price erosion.
Price Projections
Pricing Trends
When launched in 2003, Humira's list price was approximately $1,200 per month. By 2022, the average wholesale price (AWP) in the U.S. had increased to around $6,000 per month, considering inflation and market dynamics.
Impact of Biosimilars
Post-patent expiry, biosimilar prices have surpassed initial expectations with discounts ranging from 15% to 30% off the reference product in the first year, depending on pharmacy negotiation and payer contracts.
Short- to Medium-term Price Outlook (2023-2027)
| Year |
Estimated List Price per Month |
Discounted Price Range |
Factors Influencing Price |
| 2023 |
$6,200 |
$4,340 – $5,270 |
Biosimilar competition, payer negotiations |
| 2024 |
$6,300 |
$4,410 – $5,355 |
Market penetration stabilizes |
| 2025 |
$6,400 |
$4,480 – $5,440 |
Increased biosimilar uptake |
| 2026 |
$6,500 |
$4,550 – $5,530 |
Consolidated biosimilar pricing |
| 2027 |
$6,700 |
$4,690 – $5,830 |
Potential new formulary restrictions |
Drivers of Price Trends
- Biosimilar Competition: As more biosimilars gain approval and market share, reference prices are expected to decline further.
- Payer Negotiations: Increased focus on value-based contracts may result in significant rebates and discounts, lowering net prices.
- Market Penetration: Higher biosimilar adoption leads to pressure on original drug pricing.
- Regulatory Changes: Policies encouraging biosimilar substitution could accelerate price declines.
Market Access Dynamics
Contract negotiations with payers favor biosimilars for cost saving. Commercial and government insurers are increasingly adopting biosimilars, leading to pricing convergence.
Risks and Uncertainties
- Patent litigation delays: Ongoing patent disputes could prolong exclusivity.
- Regulatory hurdles: New formulations or delivery devices could modify the competitive landscape.
- Market acceptance: Prescriber and patient acceptance of biosimilars influence pricing and market share.
Key Takeaways
- Humira (NDC 69367-0307) faces intense biosimilar competition post-2023, with significant price reductions forecasted.
- Pricing in the U.S. likely to decline from approximately $6,200/month to around $4,300–$5,500/month over the next five years.
- Market share shifts driven by biosimilars, payer negotiations, and regulatory policies shape pricing trajectories.
- Long-term outlook depends on patent disputes, competitor innovation, and policy changes supporting biosimilar substitution.
FAQs
1. How does biosimilar entry affect Humira's pricing?
Biosimilar entry typically results in price discounts of 15-30%, increasing market competition and reducing Humira’s net revenue.
2. What factors influence the discount rates for biosimilars?
Discount rates depend on payer negotiations, market penetration, provider incentives, and regulatory policies.
3. Are there any upcoming patents that could extend Humira’s exclusivity?
Current patents were invalidated or expired in 2023; future patent filings might delay biosimilar proliferation, but they are unlikely to restore exclusivity.
4. How does the US market compare to Europe regarding biosimilar adoption?
The US tends to achieve more aggressive biosimilar penetration due to regulatory and reimbursement differences, leading to faster price erosion.
5. What potential developments could halt or reverse price declines?
Innovations like new formulations, delivery devices, or patent litigations that delay biosimilar launch can impact pricing trajectories.
Sources:
[1] IQVIA. (2023). 2022 Biologic Market Data.
[2] FDA. (2023). Biosimilar Approval List.
[3] Reuters. (2023). Humira Biosimilar Launch and Market Dynamics.
[4] Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Reimbursement Data.
[5] Medscape. (2023). Biologic and Biosimilar Market Overview.
