Last updated: February 23, 2026
What is NDC 69315-0127?
NDC 69315-0127 is an injectable medication developed by Sandoz, identified as Guselkumab (brand name Tremfya). It is prescribed for the treatment of plaque psoriasis, psoriatic arthritis, and other immune-related conditions.
Market Overview
Product Details
| Attribute |
Specification |
| Manufacturer |
Sandoz (a Novartis division) |
| Approval Year |
2017 |
| Indications |
Plaque psoriasis, psoriatic arthritis |
| Dosage Form |
Injection (subcutaneous) |
| Strength |
100 mg per dose |
Market Size
The global psoriasis treatment market is projected to reach USD 16.2 billion by 2028, with biologics accounting for approximately 65% of revenues[1].
Competitive Landscape
Key competitors include:
- Eli Lilly's Taltz (ixekizumab)
- AbbVie's Humira (adalimumab)
- Johnson & Johnson's Stelara (ustekinumab)
Guselkumab's market share has grown, capturing about 20% of the biologic psoriasis segment in the US[2].
Regulatory Status
Approved by the FDA in July 2017, with EU approval in 2018. It is widely used in clinical practice for moderate-to-severe plaque psoriasis.
Current Pricing and Reimbursement
Average Wholesale Price (AWP)
| Region |
Price (per 100 mg dose) |
Notes |
| United States |
USD 3,000 – USD 3,200 |
Varies by purchaser and discounts |
| European Markets |
EUR 2,500 – EUR 2,700 |
Similar price range; dependent on country |
Reimbursement
Medicare, Medicaid, and commercial insurers cover Guselkumab, typically with negotiated discounts ranging from 15% to 40%. The actual net price varies, influenced by contracts, provider discounts, and patient assistance programs.
Pricing Trends and Projections
Historical Price Trends
From 2017 to 2023, US wholesale prices increased approximately 10% annually, driven by inflation, manufacturing costs, and market positioning.
Market Penetration
Guselkumab has steadily increased market share within biologics for psoriasis, reaching approximately 20% in the US psoriasis segment during 2022[2].
Price Projection (2023-2028)
| Year |
Estimated Average Price (USD per dose) |
Assumptions |
| 2023 |
USD 3,200 |
Stable, slight inflation-driven increases |
| 2024 |
USD 3,300 |
Slight market expansion, competitive pressures |
| 2025 |
USD 3,350 |
Cost pressures, potential generic bios substitutes |
| 2026 |
USD 3,400 |
Continued inflation and demand stability |
| 2027 |
USD 3,450 |
Regulatory factors, new indications emerge |
| 2028 |
USD 3,500 |
Net price stabilization, market maturity |
Influencing Factors
- New biosimilar entries could exert downward pressure by 2025.
- Expanded label indications increase potential patient pool.
- Changes in reimbursement policies may alter net prices.
Key Drivers and Risks
- Drivers: Increasing prevalence of psoriasis, expanding insurance coverage, innovation in biologic therapies.
- Risks: Entry of biosimilars, shifts in payer negotiations, regulatory changes limiting pricing flexibility, competition from oral small molecules.
Summary
Guselkumab (NDC 69315-0127) remains a high-value biologic with stable revenue streams in psoriasis treatment. Its price is projected to increase gradually, reaching approximately USD 3,500 per dose by 2028, contingent on market dynamics and competitive pressures.
Key Takeaways
- The product maintains a strong position in the biologic psoriasis space.
- Price increases are modest but steady, aligned with inflation and market factors.
- Biosimilar competition represents the primary risk to pricing stability.
- Expanding indications could support price growth and market share.
- Payer negotiations significantly influence net pricing and market access.
FAQs
Q1: How does the price of Guselkumab compare to other biologics?
Guselkumab's US wholesale price per dose (~ USD 3,200) is comparable to Taltz and Stelara but typically lower than Humira, which can exceed USD 4,000 per dose depending on formulation.
Q2: What impacts pricing strategy for this drug?
Pricing is affected by competition, reimbursement negotiations, patent status, biosimilar entry, and healthcare policies targeting biologics.
Q3: Will biosimilars significantly reduce the price of Guselkumab?
Potentially, by 2025-2026, biosimilars could reduce net prices by 20-30%, though actual impact depends on regulatory approval, market acceptance, and contracts.
Q4: How does the price trend translate into market revenue?
With approximately 20% market share and stable demand, revenue tied to target populations could grow in tandem with price increases.
Q5: What is the regulatory outlook for further price control?
Regulations may impose price caps or incentivize biosimilar uptake, challenging future pricing strategies, especially outside the US.
References
[1] Grand View Research. (2022). Psoriasis Treatment Market Size, Share & Trends Analysis.
[2] IQVIA. (2023). Biologics Market Share and Trends in US Dermatology.
Note: Data sources are industry reports and publicly available industry databases.
