Last updated: February 20, 2026
What Is the Drug Associated with NDC 55513-0710?
NDC 55513-0710 corresponds to Tafasitamab (development code: MOR208), a monoclonal antibody targeting CD19. It is developed for use in hematologic malignancies, primarily relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Market Context
Current Market Landscape
- Indication: Approved by FDA in August 2022 for adult patients with DLBCL who are ineligible for autologous stem cell transplant and have received at least one prior therapy.
- Competitors: Other CD19-targeted therapies include axicabtagene ciloleucel, tisagenlecleucel, and loncastuximab tesirine.
- Market Size: The global B-cell lymphoma market forecasted to reach $7 billion by 2025, driven by increasing incidence rates and expanding indications, including relapsed and refractory cases.
Market Drivers
- Rising incidence of DLBCL, especially in aging populations.
- Growing adoption of targeted monoclonal antibody therapies.
- Expansion of indications based on ongoing clinical trials and approval pathways.
- High unmet need in elderly and transplantation-ineligible patients.
Market Barriers
- Competition from chimeric antigen receptor (CAR) T-cell therapies with proven efficacy.
- Cost of therapy, which affects healthcare payer reimbursement.
- Limited long-term safety data for new agents.
Price Analysis
Current Price Benchmarks
- Tafasitamab is priced at approximately $11,500 to $13,000 per dose (based on average wholesale prices in early 2023) for the 30 mg/vial formulation.
- Treatment course: Typically includes multiple doses, leading to a total treatment cost ranging from $100,000 to $200,000 per patient depending on dosing schedule and duration.
Cost Comparisons
| Drug |
Typical Annual Cost |
Approved Indications |
Delivery Method |
| Tafasitamab (NDC 55513-0710) |
$100,000 - $200,000 |
R/R DLBCL, in combination with lenalidomide |
Intravenous infusion |
| Axicabtagene ciloleucel |
~$373,000 |
R/R large B-cell lymphoma (CAR T) |
Single infusion, inpatient |
| Tisagenlecleucel |
~$475,000 |
R/R DLBCL, other lymphomas |
Single infusion, inpatient |
Price Projections
- Short-term (1–2 years): Maintain current pricing due to recent approval and patent exclusivity. Prices may see minor increases linked to inflation or supply chain costs.
- Medium-term (3–5 years):
- Potential introduction of biosimilars or follow-on biologics could pressure pricing downward.
- Increased competition from CAR T-cell therapies may drive prices lower.
- Payer negotiations likely to influence discounts, especially if biosimilars enter the market.
- Long-term (5+ years):
- Price reduction estimated between 15% to 30% over the next decade owing to biosimilar entry and competitive pressure.
- Pricing may stabilize if the drug captures a niche segment—such as in elderly patients unfit for CAR T-cell therapies.
Regulatory Developments and Pricing Impact
- If further indications are approved, demand could rise, supporting sustained pricing.
- Payer restrictions and value-based pricing models might reduce reimbursement levels over time.
Sales Projections
| Year |
Estimated Global Sales |
Assumptions |
| 2023 |
$350 million |
Initial launch in US, moderate adoption |
| 2024 |
$500 million |
Expanded indications, increased market share |
| 2025 |
$700 million |
Competition, biosimilar entries influence growth |
Strategic Considerations
- Patent protection expected to extend into the late 2020s.
- Manufacturer focus on expanding indications for increased market penetration.
- Biologics market trends favoring value-based contracts to offset high costs.
Key Takeaways
- NDC 55513-0710 (Tafasitamab) is positioned in a growing DLBCL market with a current treatment cost around $11,500 to $13,000 per dose.
- Short-term pricing remains stable; medium-term projections suggest potential price erosion due to biosimilar competition.
- Sales are expected to grow through expanded indications and increased adoption, with revenues potentially reaching $700 million globally by 2025.
- Competitive landscape includes CAR T therapies, which may influence pricing strategies and market share.
- Payer negotiations and regulatory policies will significantly impact future pricing and reimbursement.
FAQs
1. What are the primary factors influencing the price of Tafasitamab?
Manufacturing costs, exclusivity period, competitive pressure, and payer negotiations.
2. How does Tafasitamab’s price compare to similar therapies?
It is less expensive per dose than CAR T therapies but similar to other monoclonal antibodies treating hematologic cancers.
3. Will biosimilars for Tafasitamab reduce its price?
Potentially, if biosimilar versions receive approval, prices could decline by 15-30% over time.
4. What is the expected impact of expanded indications on sales?
Broader use will likely increase global sales, especially if regulatory agencies approve additional indications.
5. How might regulatory policies affect future pricing?
Policies supporting biosimilar entry or value-based pricing could pressure prices downward.
References
- MarketWatch. (2023). Global B-cell lymphoma market forecast 2023–2025.
- FDA. (2022). Tafasitamab approval details.
- IQVIA. (2023). Prescription drug pricing and reimbursement data.
- Evaluate Pharma. (2023). Oncology biologics sales forecast.
- Statista. (2023). Hematologic malignancy treatment landscape.
