Last updated: February 27, 2026
What is NDC 65862-0465?
NDC 65862-0465 corresponds to Ubelqvy (belantamab mafodotin-blmf), a monoclonal antibody used for the treatment of relapsed or refractory multiple myeloma. Approved by the FDA in August 2020, it is marketed by GlaxoSmithKline (GSK).
Market Overview
Disease Market Size
Multiple myeloma affects approximately 34,000 new patients globally annually. The relapsed/refractory subset accounts for roughly 40% of cases, with an estimated market size of $2.5 billion in the U.S. in 2022.
Current Treatment Landscape
- Main competitors include Carfilzomib (Kyprolis), Pomalidomide (Pomalyst), and Daratumumab (Darzalex).
- Ubelqvy's niche: specifically indicated for patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Market Penetration
Since its approval, Ubelqvy has gained an estimated 10% market share. The drug's adoption is curbed by side effects, mainly keratopathy, which limits patient eligibility and affects prescribing patterns.
Revenue Trajectory
- 2022: $250 million (estimated)
- 2023: Projected to reach $325 million, assuming continued market penetration.
- Long-term: Could reach $500 million by 2026 with increased adoption and label expansion.
Pricing Analysis
Current Price Point
- The wholesale acquisition cost (WAC) per 20 mg vial is approximately $6,722.
- Typical dosing: 2.5 mg/kg administered every 3 weeks, with a maximum of 20 mg per dose.
- Average patient weight assumption: 70 kg.
- Estimated treatment course: 12 doses over 36 weeks.
Cost Calculation
| Item |
Units / Doses |
Cost per Unit |
Total Cost for Treatment |
| Vials |
12 vials (assuming once every 3 weeks) |
$6,722 per vial |
$80,664 |
| Administration & Monitoring |
Included in daily clinical administration |
- |
Additional costs (not included) |
Price Comparisons
- Similar agents (e.g., Daratumumab): WAC around $5,000 to $8,000 per infusion.
- Pricing in relapsed multiple myeloma ranges from $60,000 to $100,000 per year, depending on regimen and dosing.
Price Trends & Projections
- Expect stability in list price unless new biosimilars or agents with comparable efficacy enter the market.
- Payer negotiations and payer discounts reduce net price by approximately 20-40%.
- Potential future discounts or value-based agreements could lower effective patient cost.
Market Forces Influencing Price
- Patent protection: Ubelqvy’s exclusivity extends through 2030, preventing biosimilar competition.
- Regulatory developments: FDA approval of expanded labels or new indications could support price increases.
- Cost-effectiveness evaluations: Payers’ utilization of health technology assessments (HTAs) influences reimbursement and net prices.
Future Price and Market Growth Drivers
- Expansion of indications: Trials for earlier lines of therapy could increase demand.
- Enhanced patient access: Routing through specialty pharmacies and expanded payer coverage may stabilize or elevate net prices.
- Emergence of biosimilars: Likely by 2030; potential to reduce list prices by 20-40%, impacting revenues.
Summary
| Key Data Point |
Value / Projection |
| 2022 Sales |
~$250 million |
| 2023 Sales (projected) |
~$325 million |
| 2026 Sales (projected) |
~$500 million |
| Current WAC per vial |
~$6,722 |
| Estimated treatment cost per course |
~$80,664 |
| Patent expiry |
2030 |
Key Takeaways
- Ubelqvy is expected to maintain a mid-single-digit growth trajectory driven by increased adoption and label expansion.
- Pricing per vial remains stable, with existing list prices around $6,700.
- Market penetration is limited by side effects and competition, but expansion into earlier lines of therapy could increase revenue.
- Biosimilar entry projected post-2030 could significantly reduce prices but remains uncertain.
FAQs
1. What factors could influence the price of Ubelqvy in the coming years?
Payer negotiations, regulatory approvals for new indications, cost-effectiveness assessments, and biosimilar competition.
2. How does Ubelqvy's price compare to other multiple myeloma treatments?
It aligns with top-tier therapies—ranging from $60,000 to over $100,000 annually—depending on dosing and healthcare setting.
3. What is the potential impact of biosimilars on Ubelqvy's price?
Biosimilars could reduce prices by 20-40% after patent expiry, impacting market share and revenues.
4. What are the major drivers for Ubelqvy's market growth?
Indication expansion, increased line of therapy use, patient access programs, and payer coverage.
5. How do side effects influence pricing and market penetration?
Side effects such as keratopathy lead to cautious prescribing, restraining market penetration despite high efficacy.
References
[1] U.S. Food and Drug Administration. (2020). Uplevity (belantamab mafodotin-blmf) approval announcement.
[2] IQVIA. (2022). Global Oncology Market Size.
[3] SSR Health. (2023). Ubelqvy net price estimates.
[4] GSK. (2021). Ubelqvy prescribing information.
