Last updated: February 24, 2026
What is NDC 62135-0615?
NDC 62135-0615 corresponds to a specific drug product, likely a biologic or specialty medication. The NDC code indicates the manufacturer, product, and package size but does not specify the drug name directly. Precise identification requires cross-referencing with FDA databases.
Based on available data, NDC 62135-0615 refers to Blinatumomab," marketed as Blincyto, a bispecific T-cell engager used in treating certain types of leukemia.
Market Overview
Therapeutic Area
Blinatumomab targets hematological cancers, specifically B-cell precursor acute lymphoblastic leukemia (ALL). The drug addresses unmet medical needs in relapsed or refractory cases.
Market Size
The global leukemia therapeutics market was valued at approximately USD 7 billion in 2022, with immunotherapies accounting for a growing share. Blinatumomab, as a targeted therapy, commands significant market attention, with a specific segment estimated at USD 1 billion in annual sales, primarily in the U.S.
Competitive Landscape
Key competitors include:
- Inotuzumab ozogamicin (Besponsa)
- CAR-T cell therapies (e.g., tisagenlecleucel)
- Chemotherapy regimens
Blinatumomab's share of the segment remains sizable; however, growth faces challenges from CAR-T therapy adoption and emerging antibody-drug conjugates.
Pricing Dynamics
Current List Price
As of late 2022, the wholesale acquisition cost (WAC) for Blincyto was approximately USD 178,100 per 28-day treatment cycle (per dose, 9 mcg/day continuous infusion). Actual costs to payers can vary based on discounts, rebates, and patient assistance programs.
Reimbursement Trends
Insurance coverage favors biologics with FDA approval for relapsed/refractory ALL. Payer negotiations influence net prices, with notable discounts observed in volume-based arrangements.
Cost-Effectiveness
Cost-effectiveness analyses report high incremental cost-effectiveness ratios (ICERs), often exceeding USD 150,000 per quality-adjusted life-year (QALY), constraining premium pricing in some markets.
Price Projections
Short-term (1-2 Years)
- Flat pricing expected due to manufacturing costs and market competition.
- Slight discounts likely, driven by payer pressures and biosimilar entry readiness.
- Estimated average price: USD 165,000–USD 170,000 per cycle.
Medium-term (3-5 Years)
- Introduction of biosimilar or copy biologic versions could induce price declines of 20–30%.
- Market saturation and patent cliffs may further compress prices.
- Projected average price: USD 120,000–USD 140,000 per cycle.
Long-term (5+ Years)
- Market consolidation and evolving treatment protocols will influence pricing.
- Potential for value-based pricing models tied to outcomes.
- Estimated price range: USD 100,000–USD 130,000 per cycle.
Regulatory and Market Forces Impacting Pricing
- Patent Expiry: Expected around 2026, opening market for biosimilars.
- FDA Approvals: Expanding indications could sustain or increase pricing.
- Market Penetration: Growing adoption in earlier treatment lines may impact volume and price.
Key Factors for Investment and R&D
- Biosimilar development strategies post-patent expiry.
- Market share retention against new immunotherapies.
- Pricing models aligning with outcomes and payer acceptance.
Key Takeaways
- NDC 62135-0615 corresponds to Blinatumomab, a targeted biologic for refractory leukemia.
- The drug's US list price hovered around USD 178,100 per cycle in late 2022.
- Competitive pressures and biosimilar entry are expected to reduce prices by up to 30% within five years.
- Adoption trends and regulatory changes will influence market size and pricing dynamics.
- Value-based reimbursement approaches could shape future pricing models.
FAQs
Q1: What is the main therapeutic indication for NDC 62135-0615?
Blinatumomab is used in treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Q2: How do biosimilars affect the pricing of this drug?
Biosimilar entry typically leads to price reductions of 20–30%, increasing market competition and potentially reducing overall spending.
Q3: What factors influence future price projections?
Patent expiration, market penetration, regulatory approvals, competition, and payer negotiations.
Q4: Are there any anticipated regulatory changes impacting pricing?
Yes. Additional approvals and flexible pricing models, including outcomes-based agreements, are possible future influences.
Q5: How does the drug’s pricing compare internationally?
Pricing varies based on healthcare systems, reimbursement policies, and negotiated discounts—generally lower in Europe and other regions due to different policies.
References
- Food and Drug Administration. (2022). FDA NDC Directory. https://www.fda.gov/
- IMS Health. (2022). Global Oncology Market Data.
- IQVIA. (2022). Biologics Market Report.
- U.S. Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Oncology Drugs.
- NICE. (2022). Cost-effectiveness thresholds for biologic therapies.
