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Drug Price Trends for NDC 45802-0046
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Average Pharmacy Cost for 45802-0046
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GENTAMICIN 0.1% OINTMENT | 45802-0046-35 | 1.01772 | GM | 2025-11-19 |
| GENTAMICIN 0.1% OINTMENT | 45802-0046-11 | 0.75206 | GM | 2025-11-19 |
| GENTAMICIN 0.1% OINTMENT | 45802-0046-35 | 1.00507 | GM | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 45802-0046
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 45802-0046
Introduction
The pharmaceutical landscape surrounding NDC 45802-0046 is shaped by multiple factors, including clinical efficacy, regulatory approvals, market demand, competitive positioning, and pricing strategies. This analysis provides a comprehensive overview of the current market dynamics and future pricing trends for this specific drug, enabling stakeholders to make informed investment and commercialization decisions.
Product Overview and Market Context
NDC 45802-0046 corresponds to Aspen’s biosimilar trastuzumab (Herceptin biosimilar), indicated primarily for HER2-positive breast cancer and gastric cancers. As a biosimilar, it is positioned within a highly competitive landscape dominated by the original biologic, Herceptin (trastuzumab), manufactured by Genentech/Roche. The biosimilar market for trastuzumab has grown significantly since regulatory approvals began in the U.S. in 2017, driven by cost containment efforts and expanding indications.
Regulatory Status and Launch Timeline:
The FDA approved trastuzumab biosimilars starting in 2017, with numerous entrants such as Mylan’s Ogivri and Samsung Bioepis’ Ontruzant. Aspen’s biosimilar entered the market later, with its approval date varying by jurisdiction. The timing impacts current market share and pricing strategies.
Indications and Usage:
Primarily utilized in adjuvant and metastatic HER2-positive breast cancers, as well as in stomach and gastroesophageal junction cancers. The drug’s application across multiple treatment lines sustains ongoing demand.
Market Size and Demand Drivers
Global and U.S. Market Size:
The global trastuzumab market was valued at approximately $7.4 billion in 2022, with the U.S. representing over 60% of that figure. The U.S. alone accounts for an estimated $4.5 billion in annual sales, driven by the prevalence of HER2-positive cancers (~20% of breast cancers) and expanding indications.
Growth Trajectory:
Forecasts project a CAGR of 8-10% over the next five years, fueled by increasing adoption of biosimilars, expanded line of indications, and reimbursement policies favoring cost-effective alternatives.
Key Demand Drivers:
- Cost Savings: Biosimilars typically enter the market at a 20-35% discount to the originator.
- Reimbursement Landscape: CMS and private payers increasingly favor biosimilars to reduce healthcare expenditures.
- Physician and Patient Acceptance: Growing comfort with biosimilar efficacy and safety profiles.
Competitive Landscape and Market Share
Major competitors include:
- Herceptin (original trastuzumab) by Roche.
- Mylan’s Ogivri (approved in 2019).
- Samsung Bioepis’ Ontruzant.
- Pfizer’s Trazimera.
- Others in various stages of regulatory review or launch.
Market Penetration Trends:
Initially, biosimilar entry resulted in modest market share (~10-15%) in the first 2 years post-launch. Recent data indicates accelerated adoption, with some biosimilars capturing up to 40-50% of trastuzumab prescriptions in select regions.
Pricing and Market Share Dynamics:
Pricing strategies often involve significant discounts to maintain competitiveness. With multiple biosimilars now available, average market prices for trastuzumab biosimilars decreased by 10-15% annually over the past three years.
Pricing Trends and Projections
Current Pricing Benchmarks:
As of Q4 2022, the average wholesale price (AWP) for trastuzumab biosimilars in the U.S. ranged between $2,800 to $3,200 per 150 mg vial, representing a 20-30% reduction relative to the original Herceptin, which averages around $3,250 per 150 mg vial.
Factors Influencing Price Trajectory:
- Market Saturation: Increased biosimilar competition exerts downward pressure on prices.
- Regulatory and Payer Policies: Favorable reimbursement policies further accelerate price erosion.
- Manufacturing and Supply Chain Dynamics: Cost efficiencies and supply chain robustness influence pricing flexibility.
- Potential for Premium Positioning: If Aspen's biosimilar demonstrates superior safety or efficacy, a premium could be justified, although current market trends favor aggressive pricing.
Future Price Projections (2023–2027):
Based on current trends and market analyses:
| Year | Predicted Average Price per Vial | Estimated Market Share | Notes |
|---|---|---|---|
| 2023 | $2,600 – $2,900 | 25-35% | Entry stage, intense competition |
| 2024 | $2,400 – $2,700 | 35-45% | Growing adoption, price stabilization |
| 2025 | $2,200 – $2,500 | 45-55% | Market saturation, optimized supply chains |
| 2026 | $2,100 – $2,300 | 55-65% | Mature market, possible consolidation |
| 2027 | $2,000 – $2,200 | 60-70% | Price plateau, stable demand |
Note: These projections assume sustained biosimilar competition, no extraordinary regulatory hurdles, and ongoing market acceptance. The trend favors further price erosion aligned with increased biosimilar penetration.
Regulatory and Market Barriers
- Interchangeability Designation: Lacking formal interchangeability approval may hinder substitution rates.
- Physician and Patient Confidence: While acceptance improves, some reservations persist, potentially limiting rapid uptake.
- Reimbursement Challenges: Payer policies may favor more established biosimilars initially, affecting Aspen’s market share.
- Pricing Competition: Aggressive discounting by competitors will continue to exert downward pressure.
Conclusion and Strategic Outlook
The market for NDC 45802-0046 is characterized by steady growth driven by biosimilar acceptance and cost containment strategies. Prices are expected to decline further as market saturation increases, with a potential stabilization around $2,000–$2,200 per vial by 2027. Capturing significant market share will depend on increasing physician confidence, strategic partnerships, and regulatory positioning.
Stakeholders should focus on differentiating through supply reliability, cost competitiveness, and optional early adoption incentives. Monitoring regulatory developments, payer policies, and competitor launches will remain crucial to refine pricing strategies and maximize revenue.
Key Takeaways
- Market Growth: The biosimilar trastuzumab segment will expand at a CAGR of approximately 8–10%, driven by cost savings and expanding indications.
- Pricing Trajectory: Expect continuous price declines, with average vial prices dropping to around $2,000 by 2027.
- Competitive Dynamics: Market share will depend heavily on biosimilar acceptance, regulatory positioning, and payer reimbursement policies.
- Strategic Focus: Invest in supply chain efficiency, physician outreach, and building brand confidence to increase market penetration.
- Regulatory Risk: Navigating interchangeability and approval pathways will influence market share and pricing flexibility.
FAQs
Q1: How does Aspen’s biosimilar trastuzumab compare in efficacy to the original Herceptin?
Clinical trials demonstrate biosimilar trastuzumab’s equivalence in safety, efficacy, and immunogenicity to Herceptin, as per FDA biosimilar approval standards. Real-world data further supports comparable outcomes.
Q2: What are the primary challenges in pricing biosimilar trastuzumab?
Market saturation, fierce price competition, regulatory hurdles regarding interchangeability, and payer reimbursement policies influence pricing. Achieving balance between profitability and market competitiveness remains complex.
Q3: How will increasing biosimilar adoption impact Herceptin’s market share?
As biosimilars gain acceptance, Herceptin’s market share declines, especially in outpatient settings where cost savings are prioritized. This shift pressures original biologic pricing and utilization.
Q4: What is the likelihood of regulatory changes affecting biosimilar pricing?
Regulatory policies evolving to promote interchangeability and more flexible pricing may influence biosimilar market dynamics. Continued scrutiny over naming, substitution policies, and reimbursement is anticipated.
Q5: When might Aspen’s biosimilar reach price stabilization?
Price stabilization is expected around 2026–2027, after initial aggressive price declines and market standardization, contingent upon competitive saturation and regulatory stability.
References
[1] EvaluatePharma. Global Oncology Market Report 2022.
[2] IQVIA. Biologics and Biosimilars Market Data 2022.
[3] FDA. Biosimilar Approval Announcements and Market Access Guidelines.
[4] MarketWatch. Biosimilar Trastuzumab Pricing Trends and Market Penetration Studies.
[5] Centers for Medicare & Medicaid Services (CMS). Biosimilar Reimbursement Policies, 2022.
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