Last updated: March 13, 2026
What is the drug associated with NDC 70000-0023?
NDC 70000-0023 corresponds to Amgevita (biosimilar to Humira/adalimumab). It is approved for indications including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and other inflammatory conditions. Amgevita is marketed by Amgen and approved by the FDA in 2017.
How does the market landscape look for Amgevita?
Market size and growth factors
- The global adalimumab market was valued at approximately USD 22 billion in 2021 and is projected to grow at a CAGR of 5% through 2027 (Grand View Research, 2021).
- The biosimilar segment accounts for over 15% of the total adalimumab market and is expanding due to patent expirations.
- United States accounts for roughly 40% of global sales, with Europe holding nearly 30%, and the rest dispersed across Asia-Pacific and other regions.
Key competitors
| Product |
Manufacturer |
Year Approved |
List Price (USD/year) |
Indications |
| Humira (adalimumab) |
AbbVie |
2002 |
~$70,000 |
RA, Crohn’s, UC, Psoriasis, Ankylosing spondylitis |
| Amgevita |
Amgen |
2017 |
~$33,000 |
Same as Humira (biosimilar approval, marketed since 2017) |
| Imraldi |
Biogen/Samsung Biologics |
2018 |
~$32,000 |
Same indications, marketed in Europe |
| Hadlima |
Samsung Bioepis |
2019 |
~$30,000 |
US biosimilar launch (marketed since 2020) |
Market penetration
- Biosimilars like Amgevita have captured over 40% of the US adalimumab prescription volume since their market entry.
- Price competition has driven list prices downward. Biosimilars are priced 30-50% below originator.
- Payer incentives and formularies favor biosimilar uptake, further reducing patient out-of-pocket costs and increasing adoption.
Price projections overview
Factors influencing biosimilar price trajectory
- Patent expirations: Humira patents expired in the US in 2023, enabling biosimilar entry.
- Market competition: Multiple biosimilars (e.g., Amgevita, Hadlima, Imraldi, Abrilada) exert pricing pressure.
- Manufacturing efficiencies: Improvements in biologic biosimilar production reduce costs, enabling lower price points.
- Regulatory policies: Policies encouraging biosimilar substitution and generic competition influence retail prices.
Expected price trajectory
| Year |
Estimated average list price (USD/year) |
Notes |
| 2023 |
~$30,000 |
Entry of multiple biosimilars; initial discount |
| 2024 |
~$27,000 |
Increased competition; slight decrease |
| 2025 |
~$25,000 |
Market saturation; further price erosion |
| 2026 |
~$24,000 |
Stabilization as market matures |
Price comparison with originator
| Year |
Humira (USD/year) |
Amgevita (USD/year) |
Discount to originator |
| 2023 |
~70,000 |
~30,000 |
57% |
| 2025 |
70,000 |
25,000 |
64% |
Revenue estimates
- US market potential forbiosimilar adalimumab could reach USD 6-8 billion annually by 2025.
- Biosimilars are expected to capture 50-60% of prescription volumes within three years of launch.
Policy and reimbursement considerations
- US CMS and private payers increasingly favor biosimilar substitution.
- States such as Florida and California implement policies promoting biosimilar switching.
- Medicare Part B and Medicaid programs are adopting policies that favor lower-cost biosimilars.
Risks impacting price and market penetration
- Potential supply chain disruptions.
- Physician and patient acceptance lag.
- Regulatory delays or additional patent litigations.
Key Takeaways
- NDC 70000-0023 (Amgevita) targets a mature biologic market with multiple biosimilar competitors.
- Biosimilars have established pricing approximately 50% below originator levels, with further reductions projected.
- Market penetration is driven by patent expirations, payer incentives, and regulatory policies.
- Revenue potential in the US could reach USD 6-8 billion by 2025, given market share growth.
- Continued price erosion is expected as competition intensifies and market saturation occurs.
FAQs
1. How does Amgevita compare to the original Humira in pricing?
Amgevita list prices are approximately 50-55% lower than Humira’s peak prices, driven by biosimilar competition since 2017 in Europe and 2020 in the US.
2. What factors could alter price projections?
Emerging biosimilars, policy changes, manufacturing innovations, and payer strategies could accelerate or slow price reductions.
3. Is Amgevita approved for all the same indications as Humira?
Yes, it has full biosimilar approval for all indications approved for Humira, subject to regulatory and labeling specifics.
4. How is biosimilar market share expected to evolve?
Biosimilar adoption is projected to increase to over 60% of adalimumab prescriptions in the US by 2025.
5. What are the main barriers to biosimilar uptake?
Physician preferences, patent litigation, and supply chain issues remain barriers despite regulatory approval and cost incentives.
References
- Grand View Research. (2021). Adalimumab Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/adalimumab-market
- U.S. Food and Drug Administration. (2017). FDA approves Amjevita, a biosimilar to Humira. https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira
- IQVIA. (2022). Biosimilars outlook: US and global market trends. https://www.iqvia.com/solutions/promotional-marketing/biosimilars
- Medicare.gov. (2022). Biosimilars and biosimilar pricing policies. https://www.medicare.gov/coverage/biosimilar-drugs
