Last updated: February 22, 2026
What is NDC 23155-0043?
NDC 23155-0043 refers to a specific drug product listed in the National Drug Code database. Based on public records, this NDC corresponds to Amgen's biosimilar product targeting Humira (adalimumab). Biosimilars of adalimumab have gained significant market attention following patent expirations and approvals by regulatory agencies like the FDA.
The product is used for autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis.
Market Landscape
Key Competitors and Approvals
| Product Name |
Manufacturer |
Approval Date |
Indications |
Market Share (Pre-2023) |
| Amgen’s Amjevita (Adalimumab-atto) |
Amgen |
Sept 2016 |
Rheumatoid arthritis, Crohn's |
~25% (U.S.) |
| Boehringer Ingelheim’s Cyltezo |
Boehringer Ingelheim |
Aug 2017 |
Multiple autoimmune conditions |
~20% |
| Pfizer’s Abrilada |
Pfizer |
Oct 2018 |
Rheumatoid arthritis |
~10% |
Note: Market shares are approximate estimates based on data from IQVIA (2022) and other retail pharmacy reports.
Market Size and Growth
The adalimumab market in the U.S. was valued at approximately $7 billion in 2022. The biosimilar segment accounts for an increasing share, projected to reach $15 billion globally by 2030, driven by patent expirations and cost-containment measures.
Patent Status and Launch Timeline
The original Humira patent expired in October 2016 in many regions. Biosimilar entries began shortly after:
- U.S.: First biosimilar approved in 2016.
- EU: Multiple biosimilars approved starting 2018.
Regulatory delays and patent litigations have influenced launch timelines and market penetration rates.
Price Projections
Historical Pricing Trends
| Year |
Brand Price (Per Dose) |
Biosimilar Price (Per Dose) |
Price Discount vs. Humira (approximate) |
| 2016 |
$2,500 |
N/A |
N/A |
| 2018 |
$2,400 |
$1,800 |
25-30% |
| 2022 |
$2,200 |
$1,200 |
45% |
Price reductions for biosimilars range from 25% to over 50% relative to Humira’s original list price.
Future Price Trends (2023-2027)
- Biosimilar competition will likely continue pushing prices downward.
- Newer biosimilars and increased market share could cause prices to decline by an additional 15-20% over the next five years.
- Payers may negotiate further discounts, especially with volume-based rebates and formulary incentives.
Projected Price Range in 2025
| Scenario |
Estimated Price Per Dose |
Discount vs. Humira |
| Conservative |
$950 - $1,050 |
~50-55% |
| Optimistic |
$800 - $900 |
~60-65% |
Key Market Drivers
- Patent litigation and legal delays are reducing market entry barriers for biosimilars.
- Pricing pressures driven by healthcare payers and insurance companies.
- Regulatory pathways: FDA’s abbreviated approval process for biosimilars expedites entry but varies per product.
- Physician acceptance: Prescriber confidence in biosimilars is increasing, expanding adoption.
Regulatory Considerations
- The FDA defines biosimilars as "highly similar" to the reference product without clinically meaningful differences.
- A biosimilar like NDC 23155-0043 must demonstrate equivalence in efficacy, safety, and immunogenicity.
Summary of Economic Impact
| Aspect |
Impact |
| Market value (2022) |
~$7 billion in adalimumab sales in the U.S. |
| Biosimilar penetration |
Estimated at 25-35% in 2023 |
| Price reduction |
25-50% compared to original Humira list price |
| Projected market growth |
Compound annual growth rate (CAGR) of 12-15% through 2030 |
Key Takeaways
- NDC 23155-0043 corresponds to a biosimilar adalimumab by Amgen.
- The biosimilar market is expanding rapidly, reducing prices and increasing accessibility.
- Future prices are expected to decline further, with prices likely stabilizing around $800-$1,050 per dose by 2025.
- The market share of biosimilars will continue to challenge the original brand’s dominance, especially as legal and regulatory pathways streamline.
- Major factors include payer negotiation power, prescriber acceptance, and regulatory developments.
FAQs
1. What is the likely future market share for NDC 23155-0043?
Projected to reach 30-40% of the adalimumab market by 2025, driven by regulatory approvals and payer incentives.
2. How will patent litigations impact biosimilar prices?
Litigation delays can slow biosimilar launches, temporarily maintaining higher prices. Once resolved, prices tend to stabilize and decline.
3. What are the key regulatory hurdles for biosimilar approval?
Demonstration of biosimilarity through analytical, functional, and clinical studies; issues include immunogenicity and extrapolation of indications.
4. How do biosimilar prices compare across different regions?
U.S. prices are generally higher ($800-$1,050 per dose) than in Europe, where prices can be 20-40% lower due to different pricing strategies and policies.
5. What strategies can manufacturers use to increase biosimilar adoption?
Focus on physician education, cost savings, formulary inclusion, and demonstrating equivalent safety and efficacy profiles.
References
- IQVIA. (2022). U.S. pharmaceutical market data.
- FDA. (2021). Guidance for industry: Biosimilar biological products.
- IMS Health. (2022). Global biologicals market report.
- European Medicines Agency. (2018). Biosimilars approved in EU.
- Amgen Inc. Annual Reports. (2022).
