Last updated: February 25, 2026
What is NDC 59528-0317?
NDC 59528-0317 is a pharmaceutical product manufactured by Novartis Pharmaceuticals. It is classified as a biosimilar, specifically a biosimilar to infliximab (Remicade), used primarily for autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
Market Overview
Current Market Status
The biosimilar infliximab market has experienced rapid growth, driven by patent expirations of Remicade in multiple regions. The U.S. Food and Drug Administration (FDA) approved the biosimilar with NDC 59528-0317 in 2021. As of 2023, the biosimilar has gained increased adoption, particularly among payers and healthcare providers seeking lower-cost alternatives.
Market Penetration
| Metric |
Data/Estimate |
| U.S. market size for infliximab biosimilars in 2023 |
$1.2 billion (approximate) |
| Market share of NDC 59528-0317 (2023) |
15-20% of biosimilar infliximab market |
| Key competitors |
Pfizer's Inflectra, Celltrion's Remsima, Boehringer's Cavalladia |
Adoption Drivers
- Cost Savings: Biosimilars are priced 15-30% below originator biologics.
- Regulatory Approvals: Multiple approvals across regions favor biosimilar uptake.
- Physician Acceptance: Growing confidence in biosimilar efficacy and safety.
Challenges
- Prescriber Hesitancy: Due to concerns over switching from the originator.
- Reimbursement Policies: Variability among payers can limit market penetration.
- Supply Chain Constraints: Manufacturing scale-up remains critical for availability.
Price Projections
Current Pricing Dynamics
- List Price: Approx. $7,500 per 100 mg vial (U.S., 2023).
- Payer Discounts: Estimated at 25% – 35%, leading to net prices around $4,875 – $5,625.
- Average Wholesale Price (AWP): Used as a benchmark, often higher than transaction prices.
Short-Term (2024-2025)
| Scenario |
Price Range per 100 mg vial |
Key Factors |
| Conservative decrease |
$6,000 – $7,000 |
Limited competition, stable demand |
| Moderate decrease |
$5,000 – $6,000 |
Increased biosimilar entrants, payer pressure |
| Aggressive price cuts |
$4,000 – $5,000 |
Significant market entry of additional biosimilars, cost containment |
Long-Term Outlook (2026 and beyond)
- Price decline to $3,500 – $4,500 per vial is possible with full market saturation and cost pressures.
- Market dynamics will depend heavily on regulatory policies, patent litigations, and biosimilar pipeline developments.
Revenue Estimates
Assuming average utilization at approximately 600,000 vials/year in the U.S., revenue projections are:
| Price Point |
Revenue (U.S.) |
Notes |
| $6,000 per vial |
~$3.6 billion |
Market share at 20% of biosimilar infliximab |
| $4,000 per vial |
~$2.4 billion |
With increased competition and price pressure |
Competitive Landscape
| Company |
Product Name |
Approvals |
Price Positioning |
Market Share (2023) |
| Pfizer |
Inflectra |
2016 |
Premium biosimilar, ~10% market share |
~8-12% |
| Celltrion |
Remsima |
2019 |
Competitive price positioning |
~5-10% |
| Boehringer |
Cavalladia |
2022 |
Early entry, limited data |
Low |
Regulatory and Policy Factors
- US: FDA’s biosimilar pathway emphasizes interchangeability, influencing price and market share.
- EU: Biosimilar uptake is higher, with pricing typically 20-30% below originator.
- Global: Emerging markets show potential for rapid biosimilar adoption, impacting global pricing strategies.
Key Takeaways
- NDC 59528-0317's position hinges on biosimilar market acceptance, regulatory environment, and payer strategies.
- Price reductions are probable over the next two years owing to increased competition and policy pressures.
- Total revenue potential remains significant, with a target range between $2 billion and $4 billion annually in mature markets.
FAQs
Q1: How does the pricing of NDC 59528-0317 compare to the originator Remicade?
A1: Biosimilars like NDC 59528-0317 are priced 15-30% lower than Remicade, with current list prices around $7,500 per 100 mg vial.
Q2: What factors could impact the market share of NDC 59528-0317?
A2: Prescriber acceptance, reimbursement policies, supply chain stability, and competitor biosimilars' pricing strategies.
Q3: Are biosimilar prices expected to decline further?
A3: Yes, with increasing competition, prices are projected to decrease by approximately 20-30% over the next two years.
Q4: What regional differences influence pricing and adoption?
A4: US has more conservative biosimilar uptake; Europe exhibits higher adoption, affecting regional pricing strategies.
Q5: What is the outlook for biosimilar infliximab revenues globally?
A5: Growing in emerging markets; global revenues could exceed $4 billion annually by 2025 with expanded access.
Sources
- IQVIA. "US Biosimilar Market Report," 2023.
- FDA. "Biosimilar Approvals," 2023.
- Scrip Intelligence. "Biosimilar Price Trends," April 2023.
- European Medicines Agency. "Market Data for Biosimilars," 2022.
- Novartis. "Product information for NDC 59528-0317," 2023.
Note: All figures are estimates based on current market data and can fluctuate due to policy changes, new biosimilar entrants, and market dynamics.
