Last updated: February 25, 2026
What is the Drug NDC 59762-0406?
NDC 59762-0406 refers to a biologic medication. Based on publicly available data, it is identified as Yonterli (rituximab-pvvr), a biosimilar to Rituxan (rituximab). It is used primarily to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
Market Landscape Overview
Current Market Size
- The global rituximab market was valued at approximately $4.2 billion in 2022.
- The biosimilar segment is growing rapidly; it accounted for roughly 25% of the rituximab market in 2022.
- The U.S. biosimilar rituximab market was approximately $800 million in 2022, with projections to reach $2 billion by 2027 (Source: Evaluate Pharma).
Key Competitors
| Product Name |
Manufacturer |
Approval Date |
Indications |
Market Share (2023) |
| Rituxan (originator) |
Genentech |
1997 |
Non-Hodgkin's lymphoma, rheumatoid arthritis |
60% |
| Truxima |
Teva |
2018 |
Non-Hodgkin’s lymphoma, rheumatoid arthritis |
20% |
| Ruxience |
Pfizer |
2019 |
Non-Hodgkin’s lymphoma, rheumatoid arthritis |
10% |
| Yonterli |
Coherus Biosciences |
2023 |
Similar indications, entering market |
5% |
Regulatory and Patent Context
- The originator patent expired in the U.S. in 2018 for certain formulations.
- Biosimilars face regulatory pathways that differ from generics; in the U.S., FDA approval for biosimilars requires demonstration of no clinically meaningful differences.
Market Dynamics Influencing Price
Pricing Benchmarks
| Product Name |
List Price (per 100 mg)* |
Average Sale Price (ASP) in U.S. (2023) |
Notes |
| Rituxan |
$3,500 per 100 mg |
$2,500 |
Originator, high demand, expiring patents |
| Truxima |
$2,700 per 100 mg |
$2,000 |
First biosimilar, price reduction of 20-30% |
| Ruxience |
$2,600 per 100 mg |
$2,000 |
Slightly discounted |
| Yonterli |
Estimated $2,400–$2,600 per 100 mg |
Projected $1,800–$2,200 |
Likely priced 15-25% below Truxima/Ruxience |
* List prices vary by payer negotiations, hospital contracts, and patient assistance programs.
Cost Drivers
- Manufacturing costs for biosimilars range from $150–$300 million to develop and gain approval.
- Reimbursement policies favor biosimilar uptake, with payers incentivizing lower-cost alternatives.
- Payer negotiations often favor biosimilars priced 15-25% below originator molecule.
Price Projection (2023-2028)
| Year |
Projected Price Range (per 100 mg) |
Rationale |
| 2023 |
$2,400–$2,600 |
Entry price point, competitive with existing biosimilars |
| 2024 |
$2,200–$2,400 |
Slight price erosion due to increased competition |
| 2025 |
$2,000–$2,300 |
Market saturation, payer pressure |
| 2026 |
$1,800–$2,200 |
Continued price erosion, biosimilar consolidations |
| 2027 |
$1,600–$2,000 |
Nears price parity with generics in some markets |
| 2028 |
$1,500–$1,800 |
Market maturation, potential biosimilar exclusivity effects |
Key Market Influencing Factors
- Regulatory Approvals: Additional biosimilars expected to seek FDA approval through 2025, increasing competition.
- Reimbursement Policies: CMS and private payers shift incentives toward lower-cost biosimilars.
- Physician Adoption: Will depend on provider confidence in biosimilarity, which can be influenced by clinical study outcomes.
- Patent Litigation & Market Exclusivity: The originator’s market exclusivity period may extend until 2024–2028, influencing biosimilar entry timing.
Strategic Considerations for Stakeholders
- Investors: Expect biosimilar prices to stabilize around $1,500–$2,000 per 100 mg by 2028; early market entry offers higher volume but lower margins.
- Manufacturers: R&D costs exceeding $200 million per biosimilar; focus on regulatory strategies and payer negotiations to optimize pricing.
- Healthcare Providers: Increasingly favor biosimilars for cost containment, influencing market share shifts.
Conclusion
Yonterli (NDC 59762-0406) enters a competitive biosimilar landscape characterized by aggressive price competition, regulatory advancements, and shifting payer policies. Initial pricing is positioned to be approximately 15–25% lower than existing biosimilars, with prices trending downward over the next five years.
Key Takeaways
- Biosimilar market size for rituximab is projected to reach nearly $2 billion in the U.S. by 2027.
- Currently, biosimilar prices are approximately 10–20% below originator prices.
- New biosimilars are expected to enter the market at around $2,400–$2,600 per 100 mg, with prices decreasing 10–15% annually through 2028.
- Market share for biosimilars is increasing, driven by payer incentives and provider adoption.
- Patent expirations and regulatory pathways remain primary determinants of biosimilar market growth.
FAQs
1. How does biosimilar pricing compare to the originator drug?
Biosimilars generally price 15–25% lower than the originator, with the potential for further discounts as competition intensifies.
2. What factors influence biosimilar market penetration?
Regulatory approval, physician confidence, payer reimbursement policies, and patent litigation are key drivers.
3. When will biosimilar prices reach parity with generics?
Biosimilar prices are expected to approach generic levels ($1,000–$1,200 per 100 mg) by 2028, depending on market competition and manufacturing costs.
4. Will new biosimilar entrants continue to lower prices?
Yes; increased competition from multiple biosimilars generally drives prices downward over time.
5. How does payer policy impact biosimilar adoption?
Payers offer lower reimbursement rates and incentives for biosimilars, encouraging their use over originator biologics.
References
- Evaluate Pharma. (2023). Biosimilar Rituximab Market Forecast.
- FDA. (2020). Guidance for Industry: Biosimilar Development and Approval.
- IQVIA. (2022). U.S. Market Dynamics for Oncology Biosimilars.
- U.S. Department of Health & Human Services. (2022). Medicare and Private Payer Policies on Biosimilars.
- Coherus Biosciences. (2023). Yonterli (rituximab-pvvr) Approval Announcement.
