Last updated: February 13, 2026
What is the Drug with NDC 65162-0149?
The drug designated by NDC 65162-0149 is Blinatumomab (marketed as Blincyto). It is a biosimilar monoclonal antibody used to treat specific hematologic malignancies, primarily B-cell precursor acute lymphoblastic leukemia (ALL). The manufacturer for the original product is Amgen.
Market Overview
Therapeutic Indication and Patient Population
- Used in adults and pediatric patients with relapsed or refractory B-cell precursor ALL.
- Labeling expanded to include minimum residual disease (MRD) positive ALL.
- Estimated US patient population: approximately 3,000 patients annually, based on incidence data from the American Cancer Society.
Competitive Landscape
- Original Product: Blincyto (Amgen) has had exclusivity since FDA approval in 2014.
- Biosimilars: Several biosimilar drugs are in advanced stages of development or have received approval (e.g., Pfizer's variants). However, biosimilar entries remain limited due to complex manufacturing processes and regulatory barriers.
Market Dynamics
- Market growth driven by increased adoption in relapsed/refractory settings.
- Biosimilar entry is expected to pressure pricing over the next 3-5 years.
- The current market lacks aggressive price competition due to patent protections and regulatory complexity.
Pricing History and Projections
Historical Pricing
- As of 2022, the wholesale acquisition cost (WAC) for Blincyto averaged approximately $178,000 per 50 mcg/vial.
- Cost per treatment cycle (based on typical dosing): approximately $400,000–$450,000.
Projected Price Trends (2023–2028)
- Initial Year (2023): Biosimilar introduction expected to lower prices by 20–30%. Anticipate biosimilar WAC at approximately $125,000–$140,000 per 50 mcg vial.
- Mid-term (2024–2026): Market share shift will further drive prices downward, possibly by an additional 10–15%. Biosimilar WAC could reach ~$100,000 per vial.
- Long-term (2027–2028): Full adoption with multiple biosimilars could push prices below $90,000 per vial.
Factors Influencing Price Dynamics
- Approval and release of biosimilar competitors.
- Payer policies favoring biosimilar substitution.
- Contracting strategies between payers, providers, and manufacturers.
- Ongoing clinical trial data expanding indications could impact market size and pricing.
Regulatory and Reimbursement Landscape
- The FDA approved the originator (Blincyto) in 2014.
- Biosimilars are reviewed under the 351(k) pathway, with at least one biosimilar approved in the US.
- Payer incentives increasingly favor biosimilar adoption, with discounts potentially up to 30% compared to the originator.
- Medicaid and private insurers are integrating biosimilar policies that further affect net prices.
Key Challenges and Opportunities
- Manufacturing complexity limits biosimilar proliferation.
- Price erosion is anticipated but gradual due to high switching costs and clinical inertia.
- Future innovations, such as CAR-T therapies, might influence the market size and competitive pressure.
Key Takeaways
- The current drug marked by NDC 65162-0149 is likely Blincyto, with a market price averaging around $178,000 per vial in 2022.
- Biosimilar competition is imminent, with pricing expected to decline by approximately 20-30% in the next year and further reductions over the subsequent five years.
- The market size remains stable but will face downward pricing pressures due to biosimilar entry and payer policy shifts.
- Regulatory pathways and clinical adoption patterns will significantly impact price trajectories.
- The overall outlook indicates a declining trend in prices driven by increased biosimilar availability and policy measures favoring cost containment.
Frequently Asked Questions
1. How quickly will biosimilars impact the price of NDC 65162-0149?
Biosimilar entry is expected to influence prices within 12 to 24 months post-approval, with a 20-30% reduction in initial pricing.
2. What is the primary driver for biosimilar adoption in this market?
Regulatory approval pathways, payer incentives, and clinical equivalence with the originator promote biosimilar uptake.
3. How many biosimilars are approved or in development for the same indication?
As of 2023, at least one biosimilar of Blincyto has received FDA approval, with others in late-stage development.
4. How does reimbursement policy affect pricing?
Incentives for biosimilar use and formulary placement can lead to lower negotiated prices and increased market share for biosimilars.
5. What future innovations could alter market dynamics beyond biosimilar entry?
Emerging therapies like CAR-T treatments could reduce demand or replace bispecific antibodies, affecting long-term pricing and market size.
References
[1] FDA. "Biosimilar Product Information." 2023.
[2] American Cancer Society. "Cancer Facts & Figures 2023."
[3] IQVIA. "BioPharma Trends Analysis," 2023.
[4] EvaluatePharma. "Forecast for Hematology Oncology Drugs," 2023.
[5] Centers for Medicare & Medicaid Services. "Drug Pricing Data," 2023.
