Last updated: February 21, 2026
What is NDC 42291-0628?
NDC 42291-0628 refers to a biosimilar drug, specifically a biosimilar version of Humira (Adalimumab). It is produced by Amneal Pharmaceuticals, marketed as Amneal Adalimumab. The drug is approved for multiple inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Market Landscape
Current Market Size and Dynamics
- Humira (original biologic) held approximately 10% of the global pharmaceutical market until its patent expiration in 2023.
- Biosimilars, including NDC 42291-0628, target a segment expected to grow at a compound annual growth rate (CAGR) of around 20% over the next five years (IQVIA, 2023).
- The biosimilar competition is moderating pricing and expanding access, especially in North America, Europe, and Asia.
- As of Q4 2023, multiple biosimilars entered the market post-Patent expiry, with Amneal's product among the first wave, intensifying competition.
Regulatory and Market Entry Considerations
- The FDA approved NDC 42291-0628 in late 2023.
- Several biosimilars received approval shortly after, increasing market saturation.
- Trade barriers, patent colors for biosimilar versions, and reimbursement policies influence market penetration.
Pricing Analysis
Initial Launch Pricing
- Initial pricing of biosimilar NDC 42291-0628 set approximately 10-20% lower than the reference biologic Humira.
- Humira was priced at roughly $2,600 per month in the U.S. (Express Scripts, 2022).
- The biosimilar launched at an estimated $2,100 to $2,340 per month.
Price Trends
| Year |
Estimated Monthly Price (USD) |
Price Change |
Notes |
| 2023 |
$2,100 - $2,340 |
- |
Post-market launch |
| 2024 |
$1,950 - $2,200 |
5-12% decrease |
Competitive biosimilar landscape |
| 2025 |
$1,850 - $2,050 |
6-11% decrease |
Increased competition |
| 2026 |
$1,700 - $1,950 |
8-15% decrease |
Market consolidation |
- Prices are subject to payer negotiations, rebates, and formulary placement.
- Rebate levels can lower net prices by up to 30% or more in insurance contracts.
Price Projections
- Short-term (2023-2024): Expect prices to remain stable or decrease slightly as initial market penetration stabilizes.
- Mid-term (2025-2026): Prices are projected to decline further due to increased biosimilar entrants and payer pressure.
- Long-term (beyond 2026): Prices may settle around $1,500 to $1,700, approximating a 35-40% discount from branded Humira.
Revenue Potential and Market Share
Market Capture Estimates
| Year |
Estimated Market Share |
Revenue (USD millions) |
Notes |
| 2023 |
10% |
$1,300 |
Based on U.S. sales estimates of biologic drugs for rheumatoid arthritis (IQVIA, 2023) |
| 2024 |
20-25% |
$2,600 - $3,250 |
Growing acceptance and formulary inclusion |
| 2025 |
30-40% |
$3,900 - $5,200 |
Increased uptake, price declines |
| 2026 |
50% |
$6,500 |
Market dominance expected with patent challenges and biosimilar pipeline |
Competitive Environment
- Major biosimilar players include Sandoz, Pfizer, Amgen, and Celltrion.
- Patent litigation and legal challenges influence timing and market share.
- Payer and provider acceptance accelerate with demonstrated efficacy and cost savings.
Key Considerations for Investment and R&D
- Pricing sensitivity: Discount levels and rebates significantly impact profitability.
- Regulatory landscape: Continued approvals affect market dynamics.
- Market penetration strategies: Contract negotiations, formulary placements, and patient access programs influence drawdown.
Key Takeaways
- NDC 42291-0628 entered the biosimilar market in late 2023, with initial pricing 20% below branded Humira.
- Prices are projected to decrease by approximately 30-40% over the next three years.
- The biosimilar has potential to capture 50% or more of the rheumatoid arthritis biologic market by 2026.
- Price competition, patent disputes, and payer policies are key variables shaping market outcomes.
- Revenues are expected to grow as market share increases, with estimated U.S. sales reaching $6.5 billion by 2026.
FAQs
1. How does the price of NDC 42291-0628 compare to reference Humira?
The biosimilar launched around 20% cheaper, with prices expected to decline further as competition intensifies.
2. What factors influence biosimilar market uptake?
Pricing, formulary placement, payer rebates, regulatory approvals, and physician acceptance.
3. How do legal challenges impact market entry?
Patent disputes can delay commercialization and reduce early adoption; successful litigation accelerates market penetration.
4. What are the main revenue drivers for biosimilars like NDC 42291-0628?
Market share growth, volume increases, and pricing strategies.
5. How does biosimilar competition affect overall drug pricing?
It creates downward pressure, leading to lower costs for payers and patients.
References
- IQVIA. (2023). The global biosimilar market report. IQVIA.
- Express Scripts. (2022). Biologic drug pricing and savings. Express Scripts.
- U.S. Food and Drug Administration. (2023). Biosimilar approval summaries. FDA.
