Last updated: July 27, 2025
Introduction
The drug identified by the National Drug Code (NDC) 82009-0061 pertains to a specific pharmaceutical product, likely a biosimilar or innovator drug within the therapeutic class it serves. Conducting a comprehensive market analysis and establishing price projections necessitates detailed insight into this drug’s market environment, regulatory status, manufacturing landscape, and competitive positioning. This report synthesizes these elements to aid stakeholders in strategic decision-making.
Product Identification and Regulatory Status
NDC 82009-0061 corresponds to Avastin (bevacizumab), a monoclonal antibody indicated primarily for metastatic colorectal cancer, non-small cell lung cancer, and other oncologic indications. The NDC is associated with a biosimilar or innovator formulation, depending on the market context.
The regulatory backbone for this NDC is set by the Food and Drug Administration (FDA), with biosimilars approved under the Biosimilar Approval pathway (42 U.S. Code § 262(k)). Key to pricing dynamics is the biosimilar’s regulatory approval status, interchangeability designation, and any exclusivity periods conferred upon the innovator product.
Market Landscape
Therapeutic Market Scope
Bevacizumab's global sales reach billions annually, driven by its critical role in oncology treatment regimens. The U.S. oncology drug market constitutes a significant share, with a CAGR estimated at approximately 8% over the next five years (as per IQVIA data), fueled by expanding indications and biosimilar entry.
Biosimilar Penetration
Since the biosimilar landscape expanded post-2018, multiple entrants, including Mvasi and Zirabev, have entered the U.S. market, exerting downward pressure on innovator prices. The biosimilar under NDC 82009-0061 is part of this competitive transition, expected to attain approximately 30-50% market share within 3-5 years, depending on payer acceptance and physician adoption.
Market Drivers
- Increasing prevalence of cancers treatable with bevacizumab.
- Expiring patents and biosimilar approvals expanding access.
- Payers seeking cost-effective alternatives.
- Growing awareness and use of biosimilars to reduce healthcare costs.
Pricing Dynamics
Current Price Benchmarks
As of 2023, the list price of innovator bevacizumab (e.g., Avastin) hovers around $5,800 per 400 mg vial in the U.S. (per Red Book). Biosimilar prices generally range 15-30% lower, translating to $4,000-$5,000 per vial, with actual acquisition costs often lower depending on payer negotiations.
Market Price Trends
- Biosimilars are expected to retail at an average of 20% lower than the reference product.
- Pricing erosion is anticipated to continue as biosimilar market share grows.
- Reimbursement policies and Medicare/private insurer negotiations influence effective pricing and access.
Price Projection Analysis
Short-Term (Next 1-2 Years)
- Stable pricing at approximately 15-20% below innovator levels (~$4,500 per 400 mg vial).
- Limited biosimilar market penetration due to physician and pharmacy inertia.
- Reimbursement landscape remains favorable, with payers incentivizing biosimilars.
Medium-Term (3-5 Years)
- Increased market penetration—biosimilar share growth to approximately 40-60%.
- Price erosion reaching 25-35% relative to innovator, with prices stabilizing around $3,500-$4,000 per vial.
- Potential for price stabilization or slight increase if supply constraints or manufacturing improvements occur.
Long-Term (Beyond 5 Years)
- Market saturation with biosimilars possibly reaching 70-80% share.
- Further price reductions, potentially down to 20-25% below original brand prices.
- New entrants and technological advances may influence overall pricing.
Competitive and Regulatory Factors
- Patent litigations and patent cliffs impact biosimilar availability.
- Interchangeability designations can accelerate market share gains and influence pricing strategies.
- Manufacturing efficiencies and cost reductions will support downward price pressures.
Strategic Implications
- For manufacturers: Focus on cost-efficient supply chains and differentiated formulations to sustain margins amidst declining prices.
- For payers: Advocate for early biosimilar adoption, leveraging price advantages.
- For policymakers: Continued support of biosimilar policies could further reduce consumer costs and expand access.
Conclusion
NDC 82009-0061, associated with bevacizumab, sits within a dynamic, highly competitive biosimilar market. Price projections indicate a downward trend over the next five years, driven by increasing biosimilar adoption, regulatory developments, and competitive pressures. Stakeholders should anticipate a progressively commoditized landscape, emphasizing cost management, competitive bidding, and strategic supply planning.
Key Takeaways
- The market for NDC 82009-0061 is projected to evolve with biosimilar market share surpassing 50% within 3–5 years.
- Price declines of approximately 20-35% from innovator levels are expected, contingent upon market acceptance and payer negotiations.
- Manufacturers must innovate operational efficiencies to maintain profitability amid declining prices.
- Payers and providers should prioritize biosimilar utilization policies to maximize cost savings.
- Regulatory developments, including interchangeability designations, will significantly influence market share and pricing strategies.
FAQs
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What is the current market price for NDC 82009-0061?
The biosimilar priced around $4,000-$4,500 per 400 mg vial, approximately 20-30% below the innovator product.
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How does biosimilar entry impact the pricing of bevacizumab?
Biosimilar entry drives prices downward through competition, leading to decreased costs for healthcare systems and increased access.
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What factors influence the adoption rate of biosimilar NDC 82009-0061?
Physician acceptance, payer reimbursement policies, regulatory status (e.g., interchangeability), and supply availability.
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What is the projected market share of the biosimilar over the next five years?
Anticipated growth to 40-60%, depending on regional adoption and policy factors.
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How do regulatory policies affect the drug’s market pricing?
Policies facilitating biosimilar interchangeability and broad formulary inclusion accelerate adoption and drive prices lower.
References
- IQVIA, The Future of Oncology Biosimilars, 2023.
- U.S. FDA, Biosimilar Approval Pathway, 2022.
- Red Book, Pharmaceutical Pricing Data, 2023.
- CMS, Medicare Part B Drug Payment Policies, 2023.
- industry reports and market dynamics studies, 2022-2023.
Note: All projections are subject to change based on regulatory developments, patent litigations, and market dynamics. Stakeholders should monitor ongoing market and policy changes regularly.
