Last updated: February 21, 2026
What is the drug associated with NDC: 33342-0215?
The National Drug Code (NDC) 33342-0215 corresponds to Tafasitamab-cxix (Monjuvi), a monoclonal antibody approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is marketed by MorphoSys AG and has gained significant attention following approval in 2020.
Market Size and Demand Dynamics
Indications and Approved Uses
Tafasitamab is indicated for adult patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplant. DLBCL is the most common type of non-Hodgkin lymphoma, representing approximately 30-40% of cases globally.
Prevalence and Epidemiology
- Estimated annual incidence of DLBCL in the US: 20,000 cases.
- US market potential based on the eligible patient population: approximately 12,000 to 15,000 cases annually.
- Globally, the market could encompass 60,000 to 80,000 patients (based on epidemiological data and drug eligibility criteria).
Competitive Landscape
Tafasitamab competes mainly with CAR T-cell therapies (axicabtagene ciloleucel, lisocabtagene maraleucel), as well as other monoclonal antibody-based treatments. The key differentiator is its approval for patients ineligible for stem cell transplants, which broadens its target pool.
Current Pricing and Revenue Data
US List Price
- The average wholesale price (AWP): approximately $9,000 per dose.
- Dose administration: 1.2 mg/kg weekly for three weeks, then every three weeks.
- Estimated treatment duration: 6 to 12 months.
Revenue Estimates (2022–2023)
- MorphoSys reported initial sales of approximately $100 million in 2022.
- Peak sales projections range from $300 million to $500 million annually as adoption increases.
Price Projections and Trends
Short-Term (Next 2 Years)
- Stability in list prices due to existing US Medicare and commercial payer negotiations.
- Potential discounts or rebates expected to reduce net prices by 10–15% depending on payer contracts.
- Broader geographic adoption: Europe, Asia-Pacific, and Latin America could see entry from 2023 onward, with prices generally lower by 20–30% compared to US levels due to regional pricing regulations.
Long-Term (3-5 Years)
- Introduction of biosimilars unlikely before 2028 due to patent protections and clinical exclusivity extending into the late 2020s.
- Price erosion possible if competitors introduce alternative therapies or improved combination regimens.
- As the market matures, average prices could decline by 10–20%, aligning with trend patterns seen with other monoclonal antibodies.
Impact of Policy and Reimbursement
- US CMS and private insurers may negotiate further rebates influencing net prices.
- International price controls could suppress prices abroad, particularly in Europe and developing markets.
Market Drivers and Risks
Drivers
- Increasing incidence of DLBCL.
- Growing approval for use in earlier lines of treatment.
- Expanding clinical trial data supporting combination therapies.
Risks
- Entry of biosimilars and cheaper generics.
- Regulatory delays or label restrictions.
- Competitive landscape with CAR T-cell therapies offering curative potential.
Conclusion
Tafasitamab (Monjuvi) is positioned as a critical therapy in the relapsed/refractory DLBCL market with a current US list price around $9,000 per dose. Sales are projected to grow robustly, reaching potentially $300–$500 million annually, assuming continued uptake and geographic expansion. Price competition will likely emerge as biosimilar versions approach regulatory approval timelines around 2028.
Key Takeaways
- US list price averages around $9,000 per dose, with treatment durations of 6–12 months.
- Annual sales could reach half a billion dollars within 3–5 years.
- International markets may see prices decrease by 20–30% due to regional regulation.
- Biosimilar competition is unlikely before 2028, stabilizing revenues until then.
- Market growth driven by increased eligibility and pipeline data expansion.
FAQs
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What factors most influence tafasitamab pricing?
Insurance negotiations, regional pricing policies, and market competition primarily impact net prices.
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When are biosimilars expected for tafasitamab?
No biosimilar is currently approved; likely timeline is 2028 or later, depending on patent litigation and regulatory approvals.
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How does tafasitamab compare cost-wise to CAR T therapies?
CAR T therapies cost $370,000 to $475,000 per treatment course, significantly higher than tafasitamab's per-patient drug cost.
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What is the primary driver of market growth for tafasitamab?
Increasing incidence of DLBCL and expanded treatment indications.
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Are international prices aligned with US pricing?
No, international prices vary widely, with Europe and emerging markets generally applying lower price points.
References
[1] FDA. (2020). FDA approves Monjuvi for relapsed or refractory diffuse large B-cell lymphoma.
[2] IQVIA. (2022). Oncology market reports.
[3] MorphoSys. (2022). Financial reports and sales data.
[4] Global Data. (2023). Non-Hodgkin lymphoma market forecast.
[5] U.S. Census Bureau. (2022). Cancer epidemiology data.
