Last updated: February 17, 2026
What Is the Drug Identified by NDC 00548-5701?
NDC 00548-5701 corresponds to Tafasitamab (monoclonal antibody), marketed under the brand name Monjuvi. It is an immunotherapy approved by the U.S. FDA in August 2020 for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide.
Tafasitamab is manufactured by MorphoSys and Incyte under a collaboration agreement. It is classified as an anti-CD19 monoclonal antibody, targeting B-cell malignancies.
Current Market Status
Sales and Adoption:
- FDA approval date: August 2020.
- Initial market launch: 2021.
- Reported sales (2022): Approximately $45 million (per IQVIA data). Sales trajectory exhibits steady growth due to expanding indications and increased adoption in hematology-oncology settings.
- Market penetration: Limited but growing, primarily in large academic centers and specialty oncology clinics with access to novel immunotherapies.
Market Competitors:
- Polatuzumab vedotin: An antibody-drug conjugate for DLBCL.
- Rituximab and Obinutuzumab: CD20 antibodies still dominant in B-cell lymphomas.
- Commercial outlook: Tafasitamab competes mainly in the relapsed/refractory setting, where unmet need remains high.
Regulatory Developments:
- Additional approvals: Recently gained approval for new indications (pending or under review) such as first-line treatment for DLBCL in Europe and other regions (depending on regional submissions).
- Pipeline progress: Ongoing trials exploring combinations and new indications could expand the market.
Price Analysis
Current Pricing:
- Per-dose cost: Approximately $8,500 to $10,000.
- Total treatment cost: Based on a typical regimen (weekly infusions over several weeks), the full course can cost between $70,000 and $140,000 per patient.
Pricing Comparison:
| Drug |
Indication |
Approximate Cost per Treatment |
Notes |
| Tafasitamab (Monjuvi) |
R/R DLBCL |
$80,000 - $100,000 |
Higher than traditional mAbs |
| Rituximab |
Multiple B-cell disorders |
$5,000 - $12,000 |
Standard, widespread use |
| Polatuzumab vedotin |
R/R DLBCL |
$16,000 - $25,000 |
Cost-effective ADC option |
The premium price of Tafasitamab reflects its novel mechanism, targeted design, and performance in a niche at high unmet need.
Price Projections
Factors Influencing Future Pricing:
- Market penetration: As more data confirms efficacy, and indications expand, pricing could stabilize or increase.
- Competition: Entry of biosimilars or similar therapies could apply downward pressure.
- Reimbursement landscape: Payer acceptance and coverage policies strongly influence accessible prices.
- Manufacturing costs: Technological advances may reduce production costs, enabling lower prices over time.
Projected Price Range (Next 3-5 Years):
- Stable at current levels ($8,500–$10,500 per dose) given the limited competition.
- Potential decrease: 10-15% if biosimilars or alternative therapies gain approval.
- Potential increase: Up to 20% if new, premium indications or combination therapies are approved.
Sales Forecasts:
- 2023: Approximate sales near $55–$60 million.
- 2025: Expected to reach $150–$200 million, driven by broader clinical use and indication expansion.
- Long-term: Market share may increase moderately, but dominant players like Rituximab and newer treatments will persist as primary options.
Key Market Factors
- Cost-effectiveness: Demonstrating value over existing therapies is pivotal.
- Reimbursement policies: Influences hospital adoption and patient access.
- Innovation: New combination regimens or biomarkers could unlock additional patient populations.
- Global expansion: Europe and emerging markets are early stages, but price points may differ based on region-specific pricing and healthcare economics.
Key Takeaways
- NDC 00548-5701 (Tafasitamab) is a targeted immunotherapy for relapsed/refractory DLBCL with a limited but growing market presence.
- Current list prices per dose suggest a total treatment cost of ~$80,000–$100,000, reflecting a premium position.
- Sales are projected to rise with expanding indications and clinical adoption, reaching $150–$200 million globally by 2025.
- Price attrition is possible if biosimilars or competitive therapies enter the market, but current indications support sustained premium pricing.
- The therapy’s value proposition relies on efficacy in difficult-to-treat populations and combination strategies.
5 FAQs
Q1: What factors most influence Tafasitamab’s future price?
Market penetration, competition, reimbursement policies, and indication expansion impact pricing.
Q2: How does Tafasitamab’s cost compare to similar therapies?
It costs approximately 7 to 12 times more per treatment than earlier-generation monoclonal antibodies like rituximab.
Q3: What are main competitors in the same indication?
Polatuzumab vedotin, rituximab, obinutuzumab, and emerging CAR-T therapies.
Q4: Can biosimilars impact the market?
Yes. Biosimilar development may pressure prices downward over time once patent exclusivity ends.
Q5: What is the potential for pricing growth?
Limited growth expected unless new indications are approved or combination therapies justify higher pricing.
Sources
- FDA approval documents and label.
- IQVIA sales data, 2022.
- Market reports from Evaluate Pharma and GlobalData.
- Pricing and reimbursement policies from CMS and European agencies.
