Last updated: February 27, 2026
What is NDC 57237-0086?
NDC 57237-0086 corresponds to Fusion (Oprelvekin), a recombinant human interleukin-11 analog, used to prevent severe thrombocytopenia following chemotherapy in adult patients with non-myeloid malignancies. It is marketed under the brand name Neumega by Sandoz Inc.
Market Overview
Indications and Usage
Oprelvekin stimulates platelet production, reducing the risk of bleeding in patients undergoing myelosuppressive chemotherapy. FDA approval for Neumega was granted in 1997. Its primary use remains in oncology, specifically for chemotherapy-induced thrombocytopenia.
Market Size and Trends
The global thrombopoietic agents market was valued at approximately USD 750 million in 2021. It is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2028, driven by rising cancer prevalence and advances in supportive care.
Key Competitors
- Romiplostim (Nplate): Thrombopoietin receptor agonist.
- Eltrombopag (Promacta): Oral agent for thrombocytopenia.
- Avatrombopag (Doptelet): Approved for chronic immune thrombocytopenia.
Neumega's market share has declined since the advent of newer thrombopoietic agents, but it remains in niche oncology indications.
Market Dynamics
- Patent Status: As of 2010, Sandoz's Neumega lost patent protection, original formulations are off patent, enabling generics and biosimilars entry.
- Pricing and Reimbursement: The average wholesale price (AWP) in the US approximates USD 1,200–1,500 per mg. Reimbursement depends on national and institutional policies, with discounts and negotiations common.
- Regulatory Environment: The FDA maintains restrictions for off-label uses; off-patent status can promote biosimilar development.
Price Projections
Current Pricing
| Parameter |
Data |
| Average Wholesale Price (AWP) |
USD 1,200–1,500 per mg |
| Typical Dose in Treatment |
25-50 µg (micrograms) per dose, administered subcutaneously |
| Annual Cost |
USD 3,000–5,000 per patient (based on dosing frequency) |
Future Price Trends (2023–2028)
- Regulatory and Market Competition: Entry of biosimilars is expected to decrease prices by 20%-40% over five years.
- Market Penetration of Biosimilars: Biosimilars to recombinant cytokines may reach 30% share by 2028 in the US and EU.
- Pricing Adjustments: Tighter healthcare budgets and competitive bidding pressures might reduce per-unit pricing further, by approximately 10% annually from 2023 onward.
Assumptions
- Biosimilar availability will increase accessibility.
- Reimbursement policies will tighten, exerting downward price pressure.
- Utilization rates in oncology centers will stabilize, limiting significant price hikes.
Regional Variations
| Region |
Current Price Range (USD) |
Expected Trend |
| US |
1,200–1,500 per mg |
Price decline due to biosimilars |
| EU |
1,000–1,300 per mg |
Similar downward trend |
| Asia-Pacific |
800–1,100 per mg |
Lower baseline prices, smaller declines |
Key Market Drivers
- Growing incidence of cancers requiring chemotherapy.
- Expansion of indications for thrombopoietic agents.
- Increased adoption of biosimilars.
- Healthcare policies favoring cost-effective therapies.
Key Market Restraints
- Competition from newer agents with improved profiles.
- Limited reimbursement in certain regions.
- Slow uptake in non-oncology indications.
Strategic Insights
Investment in biosimilar development for oprelvekin could lead to significant price reductions. Companies consolidating oncology supportive care offerings may leverage existing infrastructure for biosimilar distribution and reimbursement negotiations.
Key Takeaways
- The US and EU markets account for the majority of sales.
- Price declines of 20-40% are expected over the next five years due to biosimilar entry.
- Annual treatment costs are around USD 3,000–5,000 per patient.
- Competition from other thrombopoietic agents limits Neumega’s growth.
- Market expansion depends on approval for additional indications and improved biosimilar adoption.
FAQs
1. How does the patent status affect the pricing of NDC 57237-0086?
Patent expiration facilitates biosimilar entry, leading to increased competition and price reductions.
2. What is the projected timeline for biosimilar penetration?
Biosimilar market share is expected to reach approximately 30% in oncology indications by 2028.
3. Are there alternative drugs to oprelvekin with higher efficacy?
Yes, agents like romiplostim and eltrombopag are alternatives, often with different administration routes and indications.
4. What regions are most likely to see price reductions?
The US and European markets will experience the largest declines due to higher biosimilar adoption.
5. How might healthcare policy changes impact the market?
Cost-containment measures may accelerate biosimilar adoption, further reducing prices.
References
[1] Market Research Future. (2022). Thrombopoietic agents market analysis.
[2] IQVIA. (2021). Global oncology supportive care market report.
[3] U.S. Food and Drug Administration. (1997). FDA approval documents for Neumega.
[4] Evaluate Pharma. (2022). Oncology supportive care market forecasts.
[5] Healthcare Market Insights. (2023). Biosimilar entry and impact assessment.
