Last updated: February 20, 2026
What is NDC 51672-4231?
NDC 51672-4231 refers to a medication registered in the National Drug Code directory. It is an injectable biologic, specifically a biosimilar to adalimumab (Humira), used primarily for autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. The drug is marketed under the brand name "Yusimry."
Market Landscape Overview
Therapeutic Area and Competition
Yusimry fits within the anti-TNF biologic sector, with key competitors including:
- Humira (AbbVie)
- Amgevita (Amgen)
- Imraldi (Bristol-Myers Squibb)
- Hyrimoz (Sandoz)
- Cyltezo (Boehringer Ingelheim)
The biosimilar market for adalimumab gained momentum after patent expiry of Humira in late 2018, particularly impacting U.S., European, and Japanese markets.
Market Size and Growth
The global adalimumab market was valued at approximately $20 billion in 2022. It is projected to grow at a CAGR of about 8% from 2023 to 2028, driven by increased prevalence of autoimmune diseases, expanded indications, and biosimilar adoption.
In the U.S., the biosimilar segment for adalimumab is estimated to account for nearly 35% of adalimumab prescriptions by 2025, up from less than 10% in 2020.[1]
Pricing Dynamics
Biosimilar entry has driven price reductions. Average wholesale prices (AWP) for biosimilars are approximately 15-30% below the reference product. In the U.S., the average price per dose for Humira was roughly $2,300 prior to biosimilar competition, with biosimilars selling at approximately $1,600-$2,000 per dose.
Regulatory Status and Market Access
Yusimry received FDA approval in mid-2022, following approval in Europe and Japan earlier that year. Payers favor biosimilars due to lower costs, increasing formulary inclusion. However, market penetration varies by region due to provider familiarity, rebate structures, and patent litigation.
Financial Performance and Pricing Trends
Current Pricing
As of Q1 2023:
| Region |
Average Wholesale Price (Per Dose) |
Market Share of Biosimilars |
| U.S. |
$1,600 - $2,000 |
Approximately 25% in 2023 |
| EU |
€1,200 - €1,500 |
40-50% penetration |
| Japan |
¥178,000 - ¥200,000 |
Growing rapidly |
Market Penetration and Revenue Projections
Based on prescription data:
- Biosimilar sales projected to surpass $7 billion globally in 2023.
- Yusimry is expected to secure a 10-15% share within biosimilar adalimumab sales in 2023.
Price Trajectory Outlook
Over the next five years, biosimilar prices are forecasted to decrease further, with typical discounts expanding to 30-40% below originator prices in mature markets, driven by competitive pressures.
| Year |
Expected Biosimilar Price Range (Per Dose) |
Key Factors |
| 2023 |
$1,600 - $2,000 |
Market entry, established biosimilar landscape |
| 2024 |
$1,400 - $1,800 |
Increased biosimilar competition, payer negotiations |
| 2025 |
$1,200 - $1,600 |
Price stabilization, expanded adoption |
Strategic Implications
- Market Penetration: Gaining share depends on payer uptake, provider acceptance, and pharmacovigilance.
- Pricing Strategy: Initial price positioning should consider market entry discounts but anticipate further reductions aligned with competitive entry.
- Regulatory and Patent Challenges: Patent litigations and regulatory pathways may affect market timing and price stability.
Key Takeaways
- The biologic market for adalimumab biosimilars is expanding, with significant price declines predicted as competition intensifies.
- Initial prices for Yusimry are roughly 15-20% below Humira's pre-competition level but will trend downward.
- Market share depends heavily on regional regulatory approval, payer policies, and brand trust.
- The biosimilar sector is projected to grow at around 8% annually through 2028, with biosimilar sales surpassing $7 billion globally in 2023.
- Strategic market penetration will require balancing pricing, provider education, and payer negotiations.
FAQs
1. What factors influence the current and future pricing of NDC 51672-4231?
Pricing is affected by market competition, rebate negotiations, regional reimbursement policies, and biosimilar manufacturing costs.
2. How does biosimilar penetration differ between regions?
The U.S. exhibits slower penetration due to patent litigation and provider preferences, while Europe and Japan show higher adoption rates due to stronger biosimilar policies and government incentives.
3. What is the expected timeline for biosimilar price reductions?
Prices are expected to decline by 10-20% annually, reaching 30-40% discounts by 2025-2026 in mature markets.
4. How much market share can Yusimry capture in the next five years?
Potentially 10-15% of biosimilar adalimumab sales by 2025, considering current adoption trends.
5. What are the main risks affecting market growth?
Patent disputes, regulatory delays, payer resistance, and supply chain disruptions could hamper growth and pricing strategies.
References
[1] IQVIA. (2023). Global Biosimilar Market Report. IQVIA Insights.
