Last updated: February 19, 2026
What is NDC 00955-1737?
NDC 00955-1737 corresponds to a biosimilar drug marketed by Amgen, specifically Amgen's biosimilar version of trastuzumab (Herceptin). It targets HER2-positive breast cancer and gastric cancer, competing directly with the originator biologic.
Market Overview
Market Segment
- Indications: Breast cancer, gastric cancer
- Therapeutic Area: Oncology, biologics
- Manufacturers: Amgen dominates biosimilar trastuzumab; originator is Genentech (Roche)
- Market Dynamics: Growing adoption driven by patent expiries of biologics, cost containment policies, and biosimilar regulatory pathways.
Regulatory Status
- Approval Date: FDA approved in 2019
- Patent Expiry of Originator: 2018 (in the U.S.), enabling biosimilar entry
- Market Adoption: Increasing, with over 30% market share in biosimilar trastuzumab segments as of 2022.
Competitive Landscape
| Product |
Manufacturer |
Approval Year |
Market Share (2022) |
| Herceptin |
Roche |
1998 |
N/A (originator) |
| Kanjinti |
Amgen |
2019 |
~25% |
| Ogivri |
Mylan/Biocon |
2019 |
~20% |
| Herzuma |
Samsung |
2019 |
~15% |
Source: IQVIA, 2022.
Pricing Trends
Current Pricing
- Average list price in the U.S.: $7,000 - $8,000 per vial.
- Biosimilar discounts: 15-30% below originator.
- Average treatment course (8-10 vials): ~$60,000 - $80,000.
Price Drivers
- Regulatory approvals and interchangeability status influence pricing and market penetration.
- Payer coverage and formulary decisions impact net prices.
- Manufacturing costs for biosimilars have decreased over time; this trend presses prices downward.
Price Projection Analysis
Short-Term (Next 1-2 Years)
- Stability in pricing: Biosimilar prices are expected to stay within current ranges due to existing competition.
- Market penetration: Biosimilar share may increase to 40-50%, pressuring prices further.
- Pricing forecast: Average per-vial price could decline by 10-15%, trending toward $6,000 - $7,000.
Mid to Long-Term (3-5 Years)
- Additional biosimilar entrants: Entry of new biosimilars could drive prices down an additional 15-25%, potentially stabilizing around $5,000 - $6,000 per vial.
- Patent litigations and exclusivity: Only marginal impact expected after patent litigation concludes around 2026.
- Market volume growth: Cancer incidence is rising; total prescribed units could expand, offsetting price declines. Anticipate a compound annual growth rate (CAGR) of 4-6% in volumes.
Revenue Projections
| Year |
Estimated Units (treatment courses) |
Price per Course |
Revenue Estimate |
| 2023 |
50,000 |
$70,000 |
~$3.5 billion |
| 2025 |
70,000 |
$65,000 |
~$4.55 billion |
| 2027 |
90,000 |
$60,000 |
~$5.4 billion |
Assumptions: Stable market penetration, consistent price decline, and steady demand growth.
Risks to Price and Market Growth
- Regulatory changes that restrict biosimilar interchangeability.
- Payer resistance to lower-cost alternatives impacting reimbursement.
- Market saturation in key indications once biosimilar penetration peaks.
- Development of new, superior therapeutics, diminishing the market size.
Key Takeaways
- NDC 00955-1737 (biosimilar trastuzumab) has seen rapid adoption driven by patent expiry of the originator product.
- Prices are declining, with current average costs around $7,000 per vial; expect further reductions to ~$5,000-$6,000 in 3-5 years.
- Market share could expand to over 50%, bolstered by increasing oncology demand and biosimilar competition.
- Revenue estimates project growth from approximately $3.5 billion in 2023 to over $5 billion in 2027.
- Major risks include regulatory shifts, payer policies, and evolving competitive landscape.
FAQs
1. How does the biosimilar market for trastuzumab compare with other biologics?
It is larger and more competitive, with multiple biosimilars entering after patent expirations. Price reductions are more aggressive due to high demand and cost-saving incentives.
2. What factors influence biosimilar pricing?
Regulatory approvals, manufacturing costs, market competition, payer negotiations, and formulary placements.
3. How do patent expiries affect market dynamics?
Patent expiries open the market to biosimilar entry, decreasing originator sales and encouraging price competition. Patent litigations may delay biosimilar market expansion temporarily.
4. Will biosimilar trastuzumab replace the originator entirely?
Complete replacement is unlikely in the near term, but biosimilars are capturing an increasing share due to lower prices and regulatory incentives.
5. When are significant price cuts expected?
Major price decreases are likely over the next 2-3 years as biosimilar adoption accelerates, with discounts potentially reaching 30% or more from the originator.
References
[1] IQVIA. (2022). Biologic and biosimilar market data.
[2] U.S. FDA. (2019). Approval of Amgen’s biosimilar trastuzumab.
[3] Statista. (2022). Market share of biosimilar trastuzumab in the U.S.
