Last updated: February 26, 2026
What is the Drug?
NDC 52817-0800 corresponds to Ontruzant (trastuzumab-dttb), a biosimilar to Herceptin (trastuzumab). It is used in treating HER2-positive breast cancer, gastric cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. Developed by Samsung Bioepis and marketed by Biogen, it was approved by the FDA on December 11, 2019.
Market Size and Dynamics
Therapeutic Indications
| Indication |
Patient Population |
Annual U.S. Prescriptions (Estimate) |
| HER2-positive breast cancer |
300,000 patients globally |
Tiries about 70,000 prescriptions (2019-2022) |
| Gastric and gastroesophageal cancers |
20,000-30,000 in U.S. |
3,000–5,000 prescriptions annually |
Market Penetration
- Biosimilars to trastuzumab entered the U.S. market efficiently after 2019.
- Estimated biosimilar market share captured by NDC 52817-0800 grew from 0% in 2019 to approximately 20% in 2022.
- The patent exclusivity of Herceptin expired in December 2019, enabling biosimilar entry.
Competitive Landscape
| Biosimilar Product |
Launch Year |
Market Share (as of 2022) |
Price Differentiation |
| Ontruzant |
2019 |
15-20% in U.S. |
15-25% lower than Herceptin |
| Herzuma |
2018 |
25-30% in U.S. |
10-20% lower than Herceptin |
| Kanjinti |
2019 |
15% in U.S. |
20-25% lower than Herceptin |
Note: Exact market share varies by source; actual data may fluctuate.
Pricing Trends and Forecasts
Current Price Points
| Product |
Loading Dose |
Per 150 mg Dose |
Average Annual Cost (U.S.) |
Launch Price (2019) |
Discount Margin (Compared to Herceptin) |
| Herceptin |
$4,350 |
$4,350 |
$77,000 (per year) |
Baseline |
N/A |
| Ontruzant |
$3,660 |
$3,660 |
$65,000 |
~$4,900 / 150 mg vial |
18-20% lower |
| Herzuma |
$3,925 |
$3,925 |
$70,000 |
~$4,500 |
15-20% lower |
| Kanjinti |
$4,000 |
$4,000 |
$68,000 |
~$4,700 |
15-20% lower |
Price Projection (Next 3–5 Years)
- Biosimilar prices expected to decline further as market competition intensifies.
- A decrease of 15-25% over the next three years is plausible due to increased biosimilar adoption.
- The price of NDC 52817-0800 could settle around $3,250–$3,500 per 150 mg vial by 2026.
Factors Influencing Price Trends
- Increasing market penetration and biosimilar competition.
- Manufacturer discounting strategies to gain market share.
- Physician and hospital adoption policies favoring biosimilars.
- Payer negotiations and formulary placements favoring cost savings.
- Regulatory and patent litigation landscape.
Regulatory and Policy Environment
- FDA approved biosimilars such as Ontruzant in December 2019.
- CMS and private payers prioritize biosternals with demonstrated cost savings.
- Policies encouraging biosimilar substitution are expanding, with some states implementing mandatory substitution laws.
Key Takeaways
- The U.S. biosimilar market for trastuzumab is expanding, with NDC 52817-0800 capturing an increasing share.
- Price points are currently 15-20% below reference biologic Herceptin, with further declines expected.
- The market is influenced by biosimilar competition, payer policies, and provider adoption.
- Price projections suggest a continued downward trend, with possible stabilization in the $3,250–$3,500 range per vial by 2026.
- Market growth hinges on ongoing patent challenges, regulatory approvals, and physician prescribing behaviors.
FAQs
1. What are the primary drivers of biosimilar adoption for trastuzumab?
Cost savings, payer mandates, and physician familiarity influence increased biosimilar use.
2. How does the price of NDC 52817-0800 compare to Herceptin?
It is typically 15-20% cheaper, depending on the market and negotiation context.
3. What barriers could slow biosimilar uptake?
Brand loyalty, patent litigation, limited physician prescribing incentives, and regulatory hurdles.
4. Are biosimilar prices expected to fall further?
Yes, further reductions are anticipated over the next three years due to market saturation and intensified competition.
5. How does the regulatory environment affect biosimilar pricing?
Streamlined FDA approval facilitates market entry; policies promoting generic substitution support price declines.
References
- U.S. Food and Drug Administration. (2019). FDA Approves First Biosimilar for Trastuzumab. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-trastuzumab
- IQVIA. (2022). Prescription Drug Market Outlook.
- GoodRx. (2023). Trastuzumab biosimilar pricing comparison.
- Centers for Medicare & Medicaid Services. (2022). Biosimilar policy updates.
- MarketWatch. (2023). Biosimilar trastuzumab market analysis.
Note: Data based on publicly available sources as of Q1 2023; actual prices and market shares may vary.
