Last updated: August 8, 2025
Introduction
NDC 65862-0829 corresponds to Tafasitamab (MOR208), a monoclonal antibody developed for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), particularly in cases unresponsive to initial therapies. As a relatively novel therapeutic, tafasitamab has garnered regulatory approval and clinical adoption, prompting a detailed market and pricing analysis to inform stakeholders.
Market Landscape Overview
Therapeutic Context
Tafasitamab is marketed under the brand name Monjuvi in the United States, approved by the FDA in combination with lenalidomide for adult patients with certain types of DLBCL [1]. The drug’s mechanism involves targeting the CD19 antigen, an established therapeutic target in B-cell malignancies. Compared to traditional chemotherapies, tafasitamab offers an immunotherapy option with a different safety and efficacy profile.
Market Size and Epidemiology
The global incidence of DLBCL is approximately 7 cases per 100,000 persons annually, with higher prevalence among older adults [2]. In the U.S., this translates into an estimated 20,000–25,000 new cases annually. Subpopulations with relapsed/refractory disease are smaller but present significant unmet needs, predominantly in cases resistant to standard chemo-immunotherapy.
Efforts to quantify potential market penetration reveal a lucrative but competitive space, especially as personalized medicine strategies evolve. Through recent clinical trials, tafasitamab, in combination with lenalidomide, has demonstrated improved progression-free survival (PFS) and overall response rates, underpinning its increasing foothold.
Competitive Landscape
Main Competitors
- Rituximab-based regimens remain standard; however, resistance issues prompt the adoption of novel agents like tafasitamab.
- Polatuzumab vedotin (a CD79b-directed antibody-drug conjugate) also targets relapsed DLBCL.
- Cilta-cel and CAR-T therapies (e.g., axicabtagene ciloleucel) are emerging options, especially in refractory settings.
The market share of tafasitamab will depend on its comparative efficacy, safety profile, and reimbursement dynamics versus these competitors.
Regulatory and Reimbursement Environment
Since its approval, reimbursement pathways have been established, with payers gradually incorporating tafasitamab into coverage plans contingent on clinical efficacy and cost-effectiveness analyses. Cost considerations are pivotal, given the high price points typical of emerging immunotherapies.
Pricing Analysis
Current Pricing Benchmarks
Pricing for monoclonal antibodies targeting hematologic malignancies generally ranges from $10,000 to $20,000 per infusion, translating into annual treatment costs exceeding $150,000 depending on dosing protocols.
In the case of tafasitamab, the wholesale acquisition cost (WAC) has been reported at approximately $12,000 per dose for the infused dose, with typical administration schedules involving weekly infusions over several cycles, culminating in annual costs around $120,000–$150,000 [3].
Influencing Factors on Price
- Clinical benefit: Durable responses and improved survival rates justify premium pricing.
- Manufacturing costs: Monoclonal antibody production is complex; high-quality manufacturing environments contribute to elevated costs.
- Market exclusivity: Patent protections and regulatory exclusivity influence pricing power.
- Reimbursement policies: Negotiated discounts and value-based arrangements modulate effective prices.
- Competition: The advent of biosimilars or alternative therapies could exert downward pressure.
Market Penetration and Future Price Projections
Short-Term Outlook (1–3 years)
Given the current adoption rate, projected to increase as clinical guidelines incorporate tafasitamab, prices are expected to stabilize but with potential discounts via negotiated contracts. The current list price remains stable, barring significant reimbursement shifts.
Medium to Long-Term Outlook (3–5 years)
As more clinical data solidifies tafasitamab’s efficacy, and with the potential entry of biosimilars post-patent expiry (anticipated around 2030), pricing may decline by approximately 10-20%. Additionally, increased competition from other targeted therapies or combination regimens could force price reductions.
Impact of Regulatory and Policy Changes
New biosimilar approvals or value-based reimbursement models may adapt the pricing landscape, especially in global markets. For instance, Europe’s emphasis on price negotiations could lead to more aggressive pricing strategies, potentially reducing average therapy costs by 15-30%.
Key Opportunities and Risks
Opportunities:
- Expansion into earlier lines of therapy or maintenance settings.
- Combination therapies with emerging agents could enhance efficacy, possibly supporting premium pricing.
- Patent extensions or new indications could sustain high prices.
Risks:
- Entry of biosimilars or generics post-exclusivity.
- Payer resistance to high-cost therapies without significant added benefit.
- Competitive development of alternative immunotherapies.
Conclusion
The market for NDC 65862-0829 (tafasitamab) is poised for growth within the hematologic oncology sector, driven by unmet needs in refractory DLBCL. Current pricing levels reflect the therapy’s clinical value, with a likely modest decline over time due to biosimilar competition and market dynamics. Stakeholders should monitor evolving guidelines, reimbursement policies, and competitor activity to refine strategic positioning.
Key Takeaways
- Market Potential: Significant, driven by the rising incidence of relapsed/refractory DLBCL and increasing adoption of immunotherapies.
- Pricing Stability: Current list prices are approximately $12,000 per dose, aligning with similar monoclonal antibodies.
- Future Pricing: Anticipate a 10-20% reduction over 3–5 years due to biosimilar entry and competitive pressures.
- Strategic Focus: Opportunities exist in expanding indications and combination approaches; risks revolve around biosimilar competition and payer reimbursement hurdles.
- Monitoring Trends: Continuous assessment of clinical trial outcomes, regulatory changes, and market penetration will inform pricing and investment decisions.
References
[1] Food and Drug Administration. FDA approves tafasitamab plus lenalidomide for relapsed or refractory diffuse large B-cell lymphoma. 2020.
[2] International Agency for Research on Cancer (IARC). Global cancer statistics. 2020.
[3] Industry pricing disclosures and manufacturer data. Filed public pricing reports, 2022.
FAQs
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What is the current list price for tafasitamab (NDC 65862-0829)?
The current list price is approximately $12,000 per dose, with annual treatment costs roughly between $120,000 and $150,000.
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How does tafasitamab compare to other immunotherapies in DLBCL?
Tafasitamab offers a targeted approach with demonstrated efficacy in relapsed/refractory cases, differing from CAR-T therapies with varying safety profiles and costs.
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What factors could influence future price declines?
Entry of biosimilars post-patent expiry, increased market competition, and insurer negotiations are primary factors.
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Are there upcoming regulatory changes affecting tafasitamab pricing?
Potential approval of new indications or biosimilars could alter pricing strategies; monitoring regulatory agencies is vital.
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What is the outlook for market expansion in other indications?
Clinical trials exploring tafasitamab for other B-cell malignancies could create additional revenue streams, supporting sustained or increased pricing in expanded markets.
This analysis aims to inform strategic decisions based on current market dynamics and emerging trends related to NDC 65862-0829.
