Last updated: February 20, 2026
What is NDC 60505-7089?
NDC 60505-7089 identifies a specific pharmaceutical product, which is a biosimilar version of trastuzumab marketed as Ontruzant (by Samsung Bioepis). It is used primarily in the treatment of HER2-positive breast and gastric cancers.
Market Overview
Product Classification
| Category |
Description |
| Drug Type |
Biosimilar antibody |
| Active Ingredient |
Trastuzumab (biosimilar version) |
| Approved Uses |
HER2-positive breast cancer, gastric cancer |
| Approval Date |
FDA approved August 2020 |
| Manufacturer |
Samsung Bioepis |
Market Size and Adoption
- The global trastuzumab market was valued at approximately $6.1 billion in 2022 and projected to grow at a CAGR of 8.5% through 2027.[1]
- Biosimilar adoption increased from 15% in 2019 to approximately 35% of trastuzumab sales in North America and Europe by 2022, driven by cost savings and healthcare policies favoring biosimilar use.[2]
- In the U.S., the prevalence of breast cancer treated with trastuzumab is estimated at 20,000 new cases annually, with ongoing treatment durations averaging 12 months per patient.[3]
Competition Landscape
Major competitors include:
- Herceptin (Genentech/Roche): Original biologic; $3.7 billion in annual revenue (2022).
- Kanjinti (Amgen): Biosimilar approved in 2019.
- Ontruzant (Samsung Bioepis): Approved in 2020.
- Trazimera (Pfizer): Approved in 2019.
Market share for biosimilars increased from 10% in 2020 to about 35% in 2022 in the U.S.
Regulatory Environment
- The FDA approval process for biosimilars is based on demonstrating no clinically meaningful differences in safety, purity, and potency.
- The 351(k) biosimilar pathway allows for abbreviated approval processes, reducing development costs.[4]
- Policy initiatives such as the Biosimilar Action Plan (2018) accelerate biosimilar market entry.
Price Projections
Current Pricing
- Ontruzant typically retails at approximately $5,000 - $6,000 per vial of 150 mg.
- Average retail cost per 12-month treatment course ranges from $55,000 to $65,000, considerably lower than the originator (Herceptin), which averages $70,000 - $80,000 per year.[5]
Cost Dynamics
- Biosimilars generally offer price reductions of 15-30% relative to originators.
- Prescription volume is directly related to market adoption and prescribing patterns, influenced by formulary decisions and payer policies.
Future Price Trends
- With increased biosimilar competition, prices are expected to decrease further.
- Price erosion estimates project an additional 10-15% decline over the next 3 years.
- Market penetration could lead to vial prices dropping to around $4,000 - $4,500 by 2026.[6]
Impact of Policy and Market Factors
- CMS and private payers increasingly incentivize biosimilar use.
- State legislation and biosimilar substitution laws support further uptake, potentially accelerating price declines.
Strategic Considerations
- Biosimilar market penetration is affected primarily by physician acceptance, payer reimbursement policies, and patient access.
- Manufacturers may introduce discounts, rebates, or value-based pricing models to gain market share.
- Pricing strategies will also consider the patent expiration of the originator drug, regulatory timelines, and broader healthcare reforms.
Key Takeaways
- NDC 60505-7089 (Ontruzant) is a biosimilar trastuzumab approved in 2020, with increasing market share as biosimilar adoption expands.
- The global trastuzumab market is expected to grow by nearly 9% annually, driven by breast and gastric cancer treatments.
- Prices for biosimilars are currently 15-30% lower than originator biologics, with further reductions anticipated.
- Competitive dynamics, policy changes, and physician/payer acceptance influence pricing and market share.
- By 2026, treatment course prices are projected to fall by an additional 10-15%, with vial prices around $4,000 to $4,500.
FAQs
1. What are the main factors driving biosimilar adoption for trastuzumab?
Cost savings, regulatory policies, and increasing comfort among physicians contribute to expanding biosimilar use.
2. How does the pricing of Ontruzant compare to Herceptin?
Ontruzant’s cost per treatment course is approximately 20-25% lower than Herceptin, with ongoing downward pricing trends expected.
3. What is the impact of biosimilar competition on overall market prices?
Increased competition drives prices down, improves access, and shifts market share from the originator biologic.
4. Are there geographic differences in biosimilar uptake?
Yes. The U.S. shows faster biosimilar adoption compared to Europe, partly due to different regulatory and reimbursement policies.
5. When are biosimilar patents likely to expire?
Most key patents for Herceptin expired or will expire between 2023-2025, opening pathways for biosimilar entrants.
References
- MarketsandMarkets. (2022). Biosimilars Market by Product, Application, and Region — Global Forecast to 2027.
- IQVIA. (2022). Biosimilar Market Report.
- American Cancer Society. (2022). Breast Cancer Facts & Figures.
- U.S. Food and Drug Administration. (2019). Biosimilar Development and Approval.
- GoodRx. (2023). Cost of Trastuzumab (Herceptin and biosimilars).
- EvaluatePharma. (2023). Biosimilar Outlook and Pricing Trends.
