Last updated: March 1, 2026
What Is the Drug NDC 57237-0114?
NDC 57237-0114 refers to a specific drug listed in the National Drug Code (NDC) system. According to available data, this NDC corresponds to a biosimilar or biologic originating from Teva Pharmaceuticals. Exact identification points to Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab) used in lymphoma, leukemia, and autoimmune conditions.
Market Overview
Market Size and Growth Trends
The biologics biosimilars segment, including rituximab biosimilars, has experienced intense growth due to patent expirations and increasing biosimilar acceptance. The global biosimilars market was valued at approximately $20 billion in 2022 and is projected to reach $50 billion by 2030, with a CAGR of around 11%. Rituximab biosimilars are a significant subset, with an expanding pipeline and considerable market share in North America and Europe.
Key Competitors
- Rituximab (brand: Rituxan, MabThera)
- biosimilars: Ruxience (Teva), Truxima (Celltrion), and others
The entry of multiple biosimilars has driven competition, significantly lowering prices for rituximab products.
Regulatory Environment
In the U.S., the FDA approved Ruxience in 2019, with subsequent approvals for Truxima. The biosimilar pathway reduces development time from original biologic approval, but interchangeability designation remains limited, affecting substitution policies.
Manufacturing and Supply Chain
Biosimilars like NDC 57237-0114 are produced through complex biotechnological processes involving cell cultures, purification, and stringent quality controls. Capacity expansions are ongoing, driven by demand.
Price Projections
Current Pricing Data
The average wholesale price (AWP) for Ruxience (per 10 mL vial) in 2022 averaged approximately $1,200 to $1,800, depending on the supplier and dosage. Biosimilar prices are approximately 20-30% lower than the original biologic Rituxan.
Short-Term Price Trends (Next 2 Years)
- Prices are expected to decline by 10-15% annually due to increased competition.
- Manufacturing efficiencies and biosimilar market penetration will stabilize prices further.
- Payers and pharmacy benefit managers (PBMs) are actively negotiating discounts; net prices could differ from AWP.
Long-Term Price Trends (3-5 Years)
- Biosimilar adoption in the US could reach over 65% for rituximab by 2026.
- Price erosion could reach up to 40-50% relative to original biologic prices.
- Price stabilization may occur as the market reaches saturation and patent protections expire or are challenged.
Factors Affecting Price Projections
- Market penetration rates
- Physician and patient acceptance
- Payer negotiations
- Policy shifts favoring biosimilar substitution
- Laboratory and manufacturing capacity expansion
Impact of Pricing on Market Dynamics
Lower biosimilar prices contribute to increased adoption, especially within cost-sensitive healthcare systems. This growth reduces reliance on originator biologics and prompts pricing strategies from manufacturers. Price competition might also influence profit margins, particularly for smaller biosimilar companies.
Summary Table: Price Projections (USD per 10 mL vial)
| Year |
Expected AWP Range |
Percentage Price Decrease |
Notes |
| 2023 |
1,000 - 1,500 |
-10% |
Entry phase |
| 2024 |
900 - 1,350 |
-15% |
Increase in competition |
| 2025 |
800 - 1,200 |
-20% |
Market stabilization |
| 2026 |
700 - 1,050 |
-25% |
Market saturation |
Key Takeaways
- The biosimilar in question is part of a rapidly expanding segment, with substantial market growth projected through 2030.
- Prices are expected to decline progressively over the next five years, driven by increased competition and market acceptance.
- The overall impact favors lower healthcare costs but pressures biosimilar manufacturers' margins.
- Regulatory policies and payer strategies will significantly influence pricing and market share during this period.
FAQs
1. When did FDA approve NDC 57237-0114?
Ruxience (rituximab-pvvr) was approved by FDA in April 2019.
2. How does the price of Ruxience compare to the original Rituxan?
Ruxience's AWP typically ranges 20-30% below Rituxan, with net prices potentially lower following rebates and negotiations.
3. What factors could accelerate biosimilar price declines?
Increased market penetration, formulary inclusion, payer negotiations, and signals from policymakers promoting biosimilar substitution.
4. Are there interchangeability considerations for NDC 57237-0114?
As of now, ruxience has not received FDA designation for interchangeability, affecting automatic substitution in pharmacies.
5. What is the outlook for biosimilar uptake in autoimmune diseases?
Uptake is increasing, with projections indicating over 60% market share for biosimilars in autoimmune indications by 2026.
References
[1] MarketWatch. (2023). Biosimilars market forecast. Retrieved from https://www.marketwatch.com/
[2] U.S. Food and Drug Administration (FDA). (2019). Approval of Ruxience. https://www.fda.gov
[3] IQVIA. (2022). Biosimilars market report.
[4] EvaluatePharma. (2022). Biologics & biosimilars industry forecast.
[5] Center for Biosimilars. (2022). FDA biosimilar approvals and policies.
