Last updated: February 23, 2026
What is the drug associated with NDC 65862-0287?
NDC 65862-0287 corresponds to Rylaze (asparaginase erwinia chrysanthemi), indicated for acute lymphoblastic leukemia (ALL). It is a biologic enzyme derived from Erwinia chrysanthemi, used primarily when patients develop hypersensitivity to the asparaginase derived from E. coli.
What is the current market landscape for Rylaze?
Market Segment Overview
- Indication: Primarily used in pediatric and adult ALL treatment protocols.
- Competitors:
- E. coli-derived asparaginase (e.g., Elspar, Oncaspar)
- Pegaspargase (Pegaspargase)
- Market Dynamics: Growing global incidence of ALL, increased adoption in pediatric leukemia protocols, and expanded use in relapsed/refractory cases.
Manufacturing and Distribution Footprint
- Manufactured by: Jazz Pharmaceuticals (as of 2021).
- Regulatory Status: Approved by the FDA (August 2021) under a biologics license application.
- Distribution: Available in the U.S. healthcare system, with potential expansion into international markets.
What are current pricing trends?
U.S. Price Benchmarks
- List Price: Approximate wholesale acquisition cost (WAC) per vial ranges between $4,500 and $6,300.
- Treatment Regimen: Dosing depends on patient weight and treatment cycle, leading to multiple vials per course.
| Metric |
Approximate Value |
| WAC per vial (standard dose) |
$4,500 – $6,300 |
| Average treatment course cost |
$80,000 – $120,000 |
| Reimbursement rates (private insurance) |
Close to WAC, subject to negotiation |
Price Trends vs. Competitors
- Rylaze's price aligns with E. coli-derived agents but carries a premium due to its reduced immunogenicity and improved safety profile.
- Pegaspargase's average cost is similar, though Rylaze has shown some growth in market share based on its clinical benefits.
What factors influence future pricing?
Policy and Reimbursement
- FDA approval incentivizes inclusion in treatment guidelines, affecting reimbursement.
- Coverage varies by payer; negotiations can impact net prices.
- No significant discounts or biosimilar competition currently available.
Market expansion potential
- International approval and approval in EU/Asia could increase volume.
- Expanded indications, such as use in lymphoma, may drive demand.
Cost drivers
- Manufacturing complexity increases costs relative to small molecule drugs.
- Supply chain disruptions or manufacturing issues could inflate prices.
What are projected price trajectories?
| Timeline |
Market Factors |
Price Trend |
| 2023–2025 |
Market penetration stabilizes; limited competition |
Slight increase or stabilization around current levels |
| 2026–2030 |
International expansion; potential biosimilar entrants |
Price may decrease due to biosimilar entry or increased negotiation power of payers |
| Post-2030 |
Widespread adoption, possible generic or biosimilar options |
Prices likely decline further, similar to other biologics |
Note: No biosimilars for Rylaze have received approval as of 2023, limiting downward pressure.
Key market projections summary
- Market size: Estimated at $200–$300 million in the U.S. (2023).
- Volume growth: Expected to grow annually by 5–8%, driven by increased adoption in pediatric ALL protocols.
- Price outlook: WAC remains stable with slight upward or neutral trends, but actual net prices depend on payer negotiations and future competition.
Key takeaways
- NDC 65862-0287 (Rylaze) has a growing share in ALL therapy, especially for patients hypersensitive to E. coli-based asparaginase.
- Current prices hover around $4,500–$6,300 per vial, with treatment course costs averaging up to $120,000.
- Market expansion relies on international approvals and expanded indications.
- Long-term pricing may decline with biosimilar entry but is currently constrained by manufacturing complexity.
- Adoption is expected to support modest price stability through 2025, with potential declines post-2030.
FAQs
Q1: Is Rylaze priced higher than other asparaginase formulations?
Yes. Due to its production process and safety profile, its list price per vial is typically higher than E. coli-derived options.
Q2: What factors could significantly impact Rylaze pricing?
Introduction of biosimilars, changes in reimbursement policies, and global market expansion.
Q3: How does Rylaze’s safety profile influence its market share?
Better safety profile enhances its acceptance, especially in pediatric protocols, supporting increased utilization.
Q4: Are biosimilars expected for Rylaze soon?
As of 2023, no biosimilars have received approval; development timelines are uncertain.
Q5: What is the outlook for international markets?
Regulatory approval in additional regions could expand sales but depends on local health authority decisions.
Sources
[1] Jazz Pharmaceuticals. (2022). Rylaze (asparaginase erwinia chrysanthemi-rywal) prescribing information. Retrieved from https://www.jazzpharma.com
[2] IQVIA. (2023). U.S. Pharmaceutical Pricing Data.
[3] U.S. Food and Drug Administration. (2021). FDA approval announcement for Rylaze.
[4] MarketResearch.com. (2023). Oncology biologics market report.
