Last updated: February 28, 2026
What is the Drug Associated with NDC 65862-0864?
NDC 65862-0864 corresponds to a biosimilar product of an established biologic. Based on available data, this NDC is linked to Amjevita (adalimumab-atto), a biosimilar of Humira (adalimumab), used primarily for autoimmune conditions such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
Market Size and Demand Drivers
Current Market Overview
- Humira (original biologic): Dominates the rheumatoid arthritis and plaque psoriasis markets with annual sales exceeding $20 billion globally[1].
- Biosimilars: Capture market share as patent exclusivity lapses. Amjevita entered the U.S. market in 2017, competitively priced.
- Target diseases: Rheumatoid arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa.
Market Penetration
- Biosimilar adoption: Increasing among healthcare providers driven by lower costs and insurance mandates.
- Market share estimates: Amjevita holds approximately 15-20% of the adalimumab biosimilar segment in the U.S. as of 2022[2].
Competition Landscape
| Product |
Year Approved |
Market Share (2022) |
Manufacturer |
| Humira (originator) |
2003 |
70% of adalimumab sales |
AbbVie (orig.) |
| Amjevita (adalimumab-atto) |
2017 |
15-20% |
Amgen |
| Amgen's other biosimilars |
2019-2021 |
10-15% |
Sandoz, Pfizer |
Regulatory and Pricing Environment
- U.S. Patent Landscape: Humira faced patent expiry in 2023, opening market access for biosimilars[3].
- Pricing Trends:
- Humira's list price: Approximately $5,900 per month (cost varies by payer).
- Biosimilar pricing: Typically 15-30% below originator, with some starting around $4,000 per month.
- Rebates & Negotiations: Payer rebates and pharmacy benefit manager (PBM) negotiations reduce net prices.
Price Projections
Short-Term Outlook (Next 1-2 Years)
- As patent expiration-enabled biosimilar entry solidifies, biosimilar prices are expected to stabilize around $4,200-$4,500 per month.
- Market share for Amjevita is projected to increase gradually, reaching 30-40% by 2025, based on historical biosimilar adoption rates[4].
Long-Term Outlook (3-5 Years)
- Price erosion may continue, with average biosimilar prices decreasing by 10-20% annually due to increased competition.
- The retail net price of Amjevita could fall to $3,500-$4,000 per month by 2027.
- Overall biosimilar penetration might reach 50-60% in the adalimumab market.
Revenue Projections
Based on current demand and pricing:
| Year |
Estimated Market Penetration |
Average Monthly Price |
Projected Revenue (USD, based on 100,000 patients) |
| 2023 |
20-25% |
$4,500 |
$54.0 million |
| 2025 |
35-40% |
$4,200 |
$84.0 million |
| 2027 |
55-60% |
$3,800 |
$114.0 million |
Note: These figures are approximations contingent on market dynamics, payer policies, and patient adoption rates.
Key Market and Price Risks
- Regulatory shifts: Patent litigation delays or extended exclusivity periods.
- Market rejection: Slow uptake caused by physician or patient preference for originator.
- Pricing pressures: Inflation of biosimilar prices due to manufacturing costs or limited competition.
Summary
The biosimilar market for adalimumab, led by Amjevita, is poised for growth facilitated by upcoming patent expirations and healthcare cost containment efforts. Short-term price points should stabilize around $4,200-$4,500 daily. Total revenues depend critically on market share gains, which are forecasted to reach 50-60% by 2027.
Key Takeaways
- NDC 65862-0864 is linked to Amjevita, a biosimilar of Humira.
- The market is expanding as patent protections expire, with biosimilars capturing growing revenue.
- Prices are expected to decrease over time, with projected monthly prices between $3,800 and $4,500 within five years.
- Biosimilar market share is forecasted to increase from 20% to over 50% by 2027 in the U.S.
- Revenue growth hinges on payer acceptance, competitive pricing, and patent litigation outcomes.
FAQs
1. What factors influence biosimilar adoption for NDC 65862-0864?
Physician prescribing habits, insurance reimbursement policies, and patient preferences are primary. Payer incentives and regulations also shape market penetration.
2. How does patent expiry impact the price of Amjevita?
Patent expiry removes legal barriers, allowing biosimilar competition, which leads to price reductions driven by market entry and price competition.
3. What are the differences between biosimilar and originator price trajectories?
Biosimilars generally see significant initial discounts (15-30%) and gradual price erosion as competition increases. Originator prices often remain stable or decline minimally due to higher brand loyalty and patent protections.
4. Are there regulatory challenges that could delay biosimilar market growth?
Yes. Patent litigation and exclusivity periods can delay biosimilar entry, potentially affecting price and market share projections.
5. What is the potential impact of new biosimilars entering the market?
Additional biosimilars could intensify competition, leading to further price reductions and increased market share for multiple players, compressing revenue projections.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] EvaluatePharma. (2022). Biosimilar Market Share and Adoption Trends.
[3] U.S. Food & Drug Administration. (2022). Biologics Patent Litigation.
[4] Barclays. (2022). Biosimilar Outlook for 2022 and Beyond.
