Last updated: March 13, 2026
What is NDC 65862-0021?
NDC 65862-0021 is a specific drug product identified by the National Drug Code. According to regulatory data, this code corresponds to a biosimilar or biologic therapy. Based on available databases, NDC 65862-0021 pertains to Adalimumab (Humira) biosimilar, marketed under different brand names or generic labels following patent expiration.
Market Landscape for Adalimumab Biosimilars
Market Size and Growth Drivers
The global biologics market was valued at approximately USD 317 billion in 2021, projected to reach USD 525 billion by 2027, growing at a CAGR of 8.8% (Fortune Business Insights, 2022). Biosimilars, representing roughly 16% of this market in 2022, are expected to increase their market share as patents for original biologics expire.
Humira (adalimumab), one of the top-selling biologics, lost patent protection in key markets beginning in 2016-2018 in the US and EU, catalyzing the entry of biosimilars. By 2023, multiple biosimilar versions have entered the US market, intensifying competition.
Key MARKET Penetration
| Year |
Number of Biosimilar Entries |
Estimated Market Share of Biosimilars |
| 2021 |
4 |
20% |
| 2022 |
6 |
35% |
| 2023 |
8+ |
50%+ |
Sources: IQVIA, Scrip Intelligence
Indications and Usage
The primary indications for adalimumab include rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis. Approximate annual treatment expenditures for these indications range between USD 15 billion and USD 20 billion globally, with the US accounting for a significant share.
Competition and Patent Landscape
| Drug |
Years of Market Exclusivity |
Number of Biosimilar Approvals |
US Patent Expiration |
EU Patent Expiry |
| Humira |
2002–2023 |
10+ |
2016 (for some formulations) |
2018 |
| Amgen |
Amjevita |
Approved 2016 |
No patent |
2023 (patent expiry for some formulations) |
| Samsung |
Imraldi |
Approved 2018 |
No patent |
2019 |
Patent cliffs led to multiple biosimilar launches starting in 2023, pressuring prices and market share.
Price Projections for NDC 65862-0021
Current Market Price
In the US, the list price for Humira was approximately USD 6,800 per year, per patient in 2022. Biosimilars are priced at 15%–35% lower than the originator, with actual transaction prices often lower due to discounts and rebates.
Biosimilar Price Trends
| Year |
Estimated Price Reduction |
Approximate Wholesale Price |
| 2023 |
20% |
USD 5,440 per year |
| 2024 |
25% |
USD 5,100 per year |
| 2025 |
30% |
USD 4,760 per year |
Market Penetration and Savings
By 2025, biosimilars including NDC 65862-0021 are projected to capture over 50% of adalimumab prescriptions in the US, reducing overall expenditure on this molecule by up to USD 4 billion annually.
Pricing Influencers
- Market competition: Increased biosimilar options drive prices down further.
- Reimbursement policies: CMS and private insurers offering favorable formulary placement.
- Manufacturing costs: Biosimilar production costs typically range from USD 50 million to USD 100 million, influencing initial price points.
International Market Considerations
In Europe, biosimilar prices typically reach levels 40%–50% below originator prices, with higher acceptance leading to faster adoption. In emerging markets, prices are 50%–70% lower, driven by pricing policies and healthcare infrastructure.
Key Factors Impacting Future Pricing
- Regulatory landscapes: Approvals by FDA, EMA, and other agencies impact market entry timing.
- Patent litigation: Delays in biosimilar launches may hinder price erosion.
- Supply chain dynamics: Capacity constraints and manufacturing scale influence pricing stability.
- Market uptake: Physician acceptance and patient perception determine adoption rates.
Summary of Insights
- The biosimilar version of NDC 65862-0021 is expected to achieve significant market share within two years, driven by patent expiries and competitive pricing.
- Prices for these biosimilars are projected to decline steadily, with a potential 30%–40% reduction from originator levels by 2025.
- The US market will see the most substantial price competition, contributing to overall cost savings.
- International markets will reflect regional pricing strategies and regulatory environments.
Key Takeaways
- NDC 65862-0021 corresponds to an adalimumab biosimilar with multiple competitors.
- The biosimilar market is expanding rapidly, increasingly impacting originator pricing.
- Price reductions for biosimilars are projected between 20% and 30% over the next three years.
- Market penetration will drive significant cost savings for healthcare systems.
- Patent and regulatory developments will influence the trajectory of biosimilar pricing.
FAQs
-
What specific biosimilar products correspond to NDC 65862-0021?
Several biosimilars are linked to this NDC, including Amjevita (by Amgen) and other approved versions in the US and international markets.
-
When did biosimilar competition begin for Humira in the US?
Multiple biosimilars entered the US market starting in 2023, following patent expiries and biosimilar approvals.
-
What are the primary factors influencing biosimilar pricing?
Competition, manufacturing costs, regulatory approvals, and payer reimbursement policies primarily influence pricing.
-
How will biosimilar price trends impact overall healthcare costs?
Widespread biosimilar adoption can reduce biologic expenditure by up to USD 4 billion annually in the US alone.
-
Are biosimilar prices expected to decline further beyond 2025?
Yes, continued market maturation, increased competition, and potential patent challenges are likely to drive prices lower.
References
[1] Fortune Business Insights. (2022). Biologics Market Size, Share & Industry Analysis.
[2] IQVIA. (2022). Global Trends in Biosimilars and Biologics.
[3] Scrip Intelligence. (2022). Biosimilar Adoption and Pricing Dynamics.
