Last updated: February 17, 2026
What Is NDC 71930-0056?
NDC 71930-0056 is a biological drug marketed as Hyrimoz, a biosimilar to Humira (adalimumab). It is produced by Sandoz, a Novartis division, for treatment of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and psoriasis. Approved by the FDA in December 2018, Hyrimoz entered a competitive biosimilar landscape targeting the biologics market.
What Is the Current Market Landscape for Biosimilar Adalimumab?
The biosimilar segment for adalimumab is highly competitive, with multiple firms launching products since 2018. Key competitors include:
- Amgen’s Amjevita
- Samsung Bioepis’ Hadlima
- AbbVie's Cyltezo
Market penetration has been incremental. As of 2022, biosimilars account for approximately 20% of adalimumab prescriptions in the U.S. (IQVIA).
Market Size (2022):
Global adalimumab sales reached $22 billion; biosimilars represented roughly $4.4 billion. The biosimilar share is expected to increase to 40-50% by 2026, driven by patent expirations and price competition.
U.S. Biosimilar Adoption:
In early 2023, biosimilar prescriptions grew from 15% (2021) to nearly 25%. Leading factors include payer formulary preferences, physician acceptance, and biosimilar price reductions.
What Are the Pricing Trends for NDC 71930-0056?
List Price (Wholesale Acquisition Cost, WAC):
Hyrimoz’s WAC in 2023 is approximately $1,300 per 40 mg syringe, compared to Humira’s current WAC about $2,100 per 40 mg. This indicates a list price reduction of roughly 38% relative to Humira.
Post-Discount Price:
Pharmacy benefit managers (PBMs) and payers typically secure rebates averaging 20-25%, leading to net prices approximately 10-15% lower than WAC. Actual transaction prices for hospitals and clinics are estimated around $1,100–$1,200 per syringe.
Price Projection for 2025:
Assuming continued biosimilar market growth, prices could decline further to an average of $850–$950 per syringe, driven by:
- Increased biosimilar market share
- Further rebate negotiations
- Manufacturer price adjustments to boost volume
What Factors Influence Future Market Penetration and Pricing?
Patent and Litigation Landscape:
Humira's patents expired in 2023 in the U.S., opening the market to biosimilars. Nevertheless, litigation and authorized patent extensions, such as method-of-use patents, may delay full biosimilar penetration.
Market Dynamics:
Both provider and payer acceptance influence biosimilar adoption. Payers favor biosimilars due to their lower costs, implementing formulary restrictions or tiered copayments to steer demand.
Regulatory and Policy Changes:
Proposed policies favoring biosimilar substitution and increased rebates could accelerate market share.
Manufacturing and Supply:
Capacity constraints or supply chain disruptions may temporarily influence pricing and availability.
What Are the Revenue and Investment Implications?
Revenue Projections:
Assuming a conservative 25% market share in the adalimumab segment by 2024, with an annual volume of 20 million syringes globally:
- Estimated sales volume for Hyrimoz: 5 million syringes
- Average net price: $1,100 per syringe
Total projected annual revenue: $5.5 billion.
Investment Perspectives:
Sandoz’s biosimilar portfolio expansion and clinical development pipeline position it for increased market share later in the decade, contingent on regulatory approval and market acceptance.
Key Takeaways
- NDC 71930-0056 (Hyrimoz) faces a competitive biosimilar market with multiple entrants since 2018.
- Pricing has declined from initial WAC estimates of ~$1,300 per syringe to an anticipated future range of $850–$950 per syringe.
- Biosimilar adoption is increasing but remains limited by patent litigation, provider preferences, and rebate negotiations.
- Market share gains are projected to continue, with revenue potential in the multiple billions annually, contingent on regulatory and market factors.
FAQs
1. How does NDC 71930-0056 compare to other biosimilars?
It has similar efficacy to competitors like Amjevita and Cyltezo, with slight variations in pricing and provider acceptance.
2. What are the main barriers to increased market adoption?
Patent litigation, physician familiarity, payer formulary restrictions, and rebate negotiations.
3. How might patent litigation impact NDC 71930-0056's market share?
Litigation delays or blocks biosimilar entry into the market, potentially prolonging reliance on the originator or delaying biosimilar growth.
4. What are the regulatory risks for this biosimilar?
Potential for additional patent disputes, changes in biosimilar substitution policies, or delays in approving follow-on formulations.
5. What is the outlook for biosimilar pricing over the next five years?
Prices are anticipated to decline further as biosimilar market penetration increases, with average net prices possibly falling below $900 per syringe by 2025.
Sources:
[1] IQVIA, 2022. Biosimilar Market Data.
[2] FDA. Approved Drugs Database. December 2018.
[3] Sandoz. Hyrimoz Product Monograph. 2023.
[4] Evaluate Pharma, 2023. Biosimilar Market Outlook.
