Last updated: February 28, 2026
What is NDC 58151-0428?
NDC 58151-0428 corresponds to Amgevita (adalimumab-bwwd), a biosimilar version of the originator drug Humira (adalimumab). It is approved for multiple indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.
Market Overview
Current Market Size
The global adalimumab market was valued at approximately $22 billion in 2022. The U.S. accounted for around 55% of this, driven by high prescription volumes and favorable reimbursement policies.
Key Competitors
- Humira (AbbVie): Dominates the market with sales exceeding $19 billion in 2022.
- Amgevita (AbbVie): Approved biosimilar in multiple regions, including the U.S. and Europe.
- Amjevita (Amgen/AbbVie): Approved after Amgevita in some markets.
- Cyltezo (Biosimilar, Boehringer/Ingelheim).
Market Penetration
- Biosimilar uptake varies by country, influenced by patent exclusivity periods, reimbursement policies, and physician acceptance.
- The U.S. biosimilar market for adalimumab is projected to grow at a compound annual growth rate (CAGR) of approximately 18% from 2023-2028, reaching an estimated $8 billion by 2028.
Patent Landscape
- Humira’s US patent protection expired in 2023, opening the market for biosimilars.
- Patent litigations and settlements influence biosimilar market entry and sales volumes.
Price Projections
Current Pricing
- Humira (originator): List price approximately $6,000–$6,400 per month per patient.
- Biosimilars (including NDC 58151-0428): Priced 15-30% lower than originator, typically $4,200–$5,100 per month, varies by region.
Future Pricing Trends
- Biosimilar prices are expected to decrease by 10-15% annually due to increased competition, patent litigations, and cost containment efforts.
- By 2025, average biosimilar cost could fall to $3,800–$4,500 per month in the United States.
- In Europe, biosimilar prices are already approximately 20% lower than U.S. prices, with potential for further reductions.
Market Share and Volume
- Biosimilars are projected to capture up to 70% of the adalimumab market by 2028.
- Prescription volumes for biosimilars could reach 12 million patient-months in the U.S. by 2028.
Revenue Projections (2023–2028)
| Year |
Estimated biosimilar revenue (USD Billions) |
Market share of biosimilars |
Average price per patient/month (USD) |
| 2023 |
1.2 |
20% |
$4,500 |
| 2024 |
2.4 |
35% |
$4,200 |
| 2025 |
3.4 |
50% |
$4,000 |
| 2026 |
4.8 |
60% |
$3,800 |
| 2028 |
8.0 |
70% |
$3,800 |
Sources: IQVIA (2023), EvaluatePharma (2023), Healthcare Market Reports (2023).
Regulatory and reimbursement impacts
- U.S.: CMS and private insurers increasingly favor biosimilars to contain costs, leading to preferential formulary placement.
- Europe: Reimbursement policies favor aggressive biosimilar substitution, driving prices downward.
- Global markets: Adoption depends heavily on regulatory pathways, patent litigation, and local pricing regulations.
Risks and Opportunities
- Risks: Patent litigations can delay biosimilar market penetration, and physician hesitancy may lower uptake.
- Opportunities: First-to-market advantage in biosimilars, increasing uptake as originator prices remain high.
Close Considerations
- Pending patent litigation decisions in key markets will influence sales.
- Competitive pressures from other biosimilars and the originator's attempts to sustain market share.
- Potential for value-based pricing models to modify revenue streams.
Key Takeaways
- NDC 58151-0428 is a biosimilar of Humira, entering an increasingly competitive market.
- Market share is set to grow rapidly from 2023 to 2028, targeting 70% by volume.
- Price reductions of up to 15% annually are expected, with the average month-to-month price falling to below $4,000.
- Revenues could reach approximately $8 billion worldwide by 2028, primarily driven by volume growth.
- Patent disputes and reimbursement policies remain key uncertainties.
FAQs
1. What factors influence biosimilar price declines?
Market competition, patent expirations, manufacturing efficiencies, and payer policies.
2. How does patent litigation affect biosimilar sales?
Litigations can delay market entry, reduce initial market share, or lead to settlements allowing earlier sales.
3. Are biosimilar prices sustainable at current levels?
Price reduction trends are driven by increasing competition. Sustained reductions depend on market dynamics and regulatory frameworks.
4. What regions are most receptive to biosimilar adoption?
Europe leads in adoption due to supportive policies; the U.S. follow with rapid growth expected post-patent expiry.
5. How do biosimilar reimbursement policies impact market penetration?
Policies favoring biosimilar use and formulary inclusion accelerate adoption, increasing sales volume and revenue.
References
- IQVIA. (2023). Global Biosimilars Market Report.
- EvaluatePharma. (2023). 5-Year Forecast: Biologics & Biosimilars.
- U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval.
- European Medicines Agency. (2022). Assessment Report: Biosimilar Market Dynamics.
- McKinsey & Company. (2023). Biologics and Biosimilars Pricing Strategies.
