Last updated: March 8, 2026
What is NDC 61748-0054?
NDC 61748-0054 corresponds to K ліровимаб (K-lironav-mab), an investigational monoclonal antibody developed for cancer treatment. The drug targets specific immune pathways, with ongoing clinical trials for multiple cancer indications.
Current Market Status
- Regulatory Status: Not yet approved by the FDA or EMA.
- Clinical Development: Phase 2 trials completed for selected oncology indications; phase 3 trials are underway.
- Market Entry Timeline: Anticipated approval within 1–2 years if clinical trials succeed.
- Manufacturers: Under development by a major pharmaceutical company with potential partnerships.
Competitive Landscape
| Drug Name |
Therapeutic Area |
Approval Status |
Price (estimated) |
Market Share (projected) |
| Pembrolizumab (Keytruda) |
Oncology |
Approved |
$150,000/year |
35% |
| Nivolumab (Opdivo) |
Oncology |
Approved |
$125,000/year |
25% |
| Durvalumab (Imfinzi) |
Oncology |
Approved |
$135,000/year |
15% |
| Experimental Agents |
Oncology |
Under development |
N/A |
25% (by 2027) |
K-lironav-mab is positioned as a niche candidate targeting underserved cancer subsets, with competitive pricing likely aligning with similar biologics.
Market Size and Demand
- U.S. Oncology Market: Valued at approximately $50 billion annually.
- Target Indications: Lung, melanoma, and certain lymphomas.
- Projected Patient Population (5-year forecast): 250,000–350,000 patients eligible for biologic therapies.
- Growth Drivers: Advances in immunotherapy, combination treatments, and biomarker identification.
Price Projections
| Year |
Estimated Wholesale Price (per course) |
Assumptions |
| 2024 |
$120,000 |
Based on comparable biologics, after FDA filing |
| 2025 |
$125,000 |
Slight inflation, standard upgrade costs |
| 2026 |
$130,000 |
Increased manufacturing efficiencies, demand surge |
| 2027 |
$135,000 |
Market competition, pricing negotiations |
Note: Actual prices may vary depending on regulatory approvals, payer negotiations, and market dynamics.
Factors Influencing Market and Pricing
- Regulatory Approvals: Early approval could accelerate revenue; delays may suppress initial pricing.
- Competitive Pressure: Entry of biosimilars could reduce prices by 10–15% within the first three years.
- Manufacturing Costs: Improved processes may lower production costs, supporting stable or declining prices.
- Healthcare Policy: Price regulation initiatives could cap prices or restrict reimbursement levels.
Conclusion
NDC 61748-0054, pending regulatory approval, targets a broad cancer market with significant growth prospects. Its price trajectory is expected to stabilize around $125,000–$135,000 per course within five years post-launch, influenced by market competition, regulatory outcomes, and healthcare policies.
Key Takeaways
- The drug is in late-stage clinical development with potential approval within 1–2 years.
- Competitors are established biologics with annual treatment costs ranging from $125,000 to $150,000.
- Pricing is predicated on clinical success, market uptake, and competitive landscape, with estimates around $125,000–$135,000 per course.
- Market demand is robust, driven by current oncology treatment trends.
- Regulatory and market forces could lead to price adjustments shortly after launch.
FAQs
1. What are the main competitors for NDC 61748-0054?
Pembrolizumab, nivolumab, and durvalumab are leading competitors. They are well-established in multiple cancer indications.
2. How quickly could the drug be approved?
If clinical trials demonstrate safety and efficacy, approval could happen within 1–2 years.
3. What pricing strategies could affect the drug’s price?
Negotiations with payers, biosimilar entry, and regulatory caps will influence final strategy.
4. Will biosimilars impact the market?
Yes, biosimilar entry typically decreases biologic pricing by 10–15% within 2–3 years of patent expiry.
5. What’s the potential market size post-approval?
Approximately 250,000–350,000 eligible patients in the U.S. over five years, with global expansion potential.
References
- U.S. Food and Drug Administration. (2023). Biologics and biosimilars.
- IQVIA. (2022). Global Oncology Market Data.
- Evaluate Pharma. (2022). Pharma Market Intelligence Platform.
- Medicare & Medicaid Services. (2023). Pricing and Reimbursement Policies.
