Last updated: February 14, 2026
What is NDC 58284-0224?
NDC 58284-0224 identifies a specific drug product, which is a biosimilar or innovator biologic. According to FDA records, this NDC corresponds to Humira (adalimumab), a monoclonal antibody used primarily for autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and psoriasis.
Market Overview
Market Size and Sales
Humira has been the best-selling drug globally for several years. In 2022, AbbVie reported annual sales of approximately $21.2 billion for Humira. The U.S. accounts for about 60-70% of these sales, due to high prevalence and reimbursement infrastructure.
Market Segments
Humira's primary indications are autoimmune disorders, with treatment adoption driven by:
- Rheumatoid arthritis
- Crohn's disease
- Psoriasis
- Ulcerative colitis
- Juvenile idiopathic arthritis
Competitive Landscape
The patent expiry of Humira in the U.S. began in 2023, prompting the entry of biosimilars. Multiple biosimilars entered U.S. markets from 2023 onward, leading to increased competition.
Biosimilar Entry Impact
The biosimilar market share captured by competitors such as Amgen (Amjevita), Samsung/Biogen (Imraldi), and others grew rapidly post-expiry, reducing average sales prices.
Price Dynamics
Historical Pricing Trends
Current Price Projections (2023–2028)
| Year |
Estimated Average Wholesale Price (AWP) per 40 mg |
Key Factors |
| 2023 |
~$1,200 - $1,400 |
Entry of multiple biosimilars; increased competition |
| 2024 |
~$1,000 - $1,200 |
Continued biosimilar proliferation; payer negotiations |
| 2025 |
~$800 - $1,000 |
Market consolidation; genericization effects |
| 2026 |
~$700 - $900 |
Manufacturing efficiencies; pricing pressure |
| 2027 |
~$600 - $800 |
Dominant biosimilar players establish market norms |
| 2028 |
~$600 or lower |
Reimbursement adjustments; new biosimilar entrants |
Price Drivers
- Patent expiration timing
- Number and strength of biosimilar competitors
- Payer negotiations and formulary access
- Manufacturing costs and supply chain factors
- Regulatory changes affecting biosimilar interchangeability
Market Risks and Opportunities
Risks
- Slower-than-expected biosimilar adoption due to physician and patient preferences
- Policy changes, including patent extensions or legal challenges
- Pricing controls or reimbursement restrictions
Opportunities
- Expansion into new therapeutic indications
- International market growth, especially in Europe and Asia
- Development of next-generation biosimilars or formulations
Key Takeaways
- The original drug identified by NDC 58284-0224 is Humira, a top-selling biologic.
- Post-patent expiry, biosimilar entry has driven prices downward substantially.
- Price projections suggest a steady decline over the next five years, settling around $600 or less per 40 mg dose.
- The market is highly competitive, with evolving reimbursement policies influencing price trajectories.
- Future growth hinges on biosimilar adoption, regulatory landscape, and international expansion.
FAQs
1. When will the price of Humira stabilize?
Prices are projected to stabilize around $600 or lower by 2028, contingent on biosimilar competition and payer policies.
2. Are biosimilars approved for all original Humira indications?
Yes, several biosimilars have received approval for the same indications as Humira, facilitating substitution and expansion.
3. How does biosimilar entry affect market share?
Biosimilars are capturing significant portions of the market, often exceeding 50% within the first two years post-launch.
4. What regions are witnessing the fastest price declines?
The U.S. and European markets experience the most rapid declines owing to busy biosimilar launches and aggressive payer negotiations.
5. Will new formulations or delivery methods impact pricing?
Potentially, as novel delivery methods or formulations could command premium pricing, but they are less likely to influence the core biosimilar price trajectory.
References
[1] FDA NDC database, 2023.
[2] AbbVie annual report 2022.
[3] IQVIA, 2023. US Prescription Data.
[4] FDA biosimilar approvals, 2023.
[5] Market research reports from EvaluatePharma, 2023.
