Last updated: March 16, 2026
What Is NDC 51407-0735?
NDC 51407-0735 refers to a specific drug product registered in the National Drug Code (NDC) database. It is a biosimilar version of trastuzumab, indicated for HER2-positive breast cancer and gastric cancer. Its manufacturer is Celltrion, marketed under the brand name Herzuma.
Market Landscape
Market Size and Demand
Trastuzumab biosimilars entered the U.S. market in 2017. The original branded trastuzumab (Herceptin) generated approximately $7.4 billion globally in 2021, with U.S. sales accounting for about 56%. Biosimilar penetration reached 30-45% of trastuzumab prescriptions by 2022, driven by patent expirations and cost containment strategies.
Competitive Environment
Key biosimilar competitors include:
- Pfizer’s Trazimera (trastuzumab-dttb)
- Sandoz’s Kanjinti (trastuzumab-anns)
- Samsung Bioepis/Celltrion’s Herzuma (trastuzumab-pkrb)
Market share analysis indicates that Trazimera and Kanjinti hold dominant positions, but Herzuma maintains a significant share due to earlier market entry in some regions. The biosimilars have generally gained 15-20% of the U.S. trastuzumab market as of 2022.
Regulatory and Reimbursement Factors
The FDA approved Herzuma in July 2018 via the biosimilar pathway. Reimbursement policies favor biosimilars to lower healthcare costs, with Medicare and private payers increasingly favoring biosimilars for designated cost savings.
Geographic Market Trends
- United States: Leading biosimilar adoption, with evolving policies encouraging substitution.
- European Union: Early adopter with high biosimilar penetration; price discounts of 20-35% below the reference product.
- APAC: Growing market with regional manufacturers increasing biosimilar development.
Price Projections
Historical Pricing Trends
- The original trastuzumab (Herceptin) had a list price of approximately $70,000 per year per patient in the U.S.
- Biosimilar prices range from 15% to 30% below the reference, translating to annual costs of $50,000-$60,000.
- In 2022, the average sale price for biosimilars decreased by 10-15% compared to 2021, influenced by competitive pressures.
Forward Price Estimates (Next 3-5 Years)
| Year |
Average Biosimilar Trastuzumab Price |
Price Change (Year-on-Year) |
Notes |
| 2023 |
$45,000 - $55,000 |
-5% to -8% |
Continued price erosion driven by competition |
| 2024 |
$43,000 - $52,000 |
-4% to -7% |
Adoption accelerates; cost pressures persist |
| 2025 |
$41,000 - $50,000 |
-3% to -6% |
Market stabilizes around these levels |
| 2026 |
$39,000 - $48,000 |
-3% to -4% |
Potential premium dissipation across biosimilar market |
Price Drivers
- Market Competition: Entry of additional biosimilars and generic biologics exerts downward pressure.
- Reimbursement Policies: Payer negotiations and formulary placements impact net prices.
- Manufacturing Costs: Biosimilar production costs influence minimum sustainable prices.
- Regulatory Approvals: Expansion into new markets and indications may affect volume and pricing.
Key Market Risks and Opportunities
Risks
- Regulatory Delays: FDA or international regulatory challenges could slow adoption.
- Patent litigations or exclusivity periods: Potential legal barriers against biosimilar entry.
- Pricing Volatility: Payers’ negotiation power could depress prices further.
Opportunities
- New Indications: Expansion into additional cancer treatments could increase utilization.
- Elderly Population Growth: Aging demographics heighten demand for cost-effective cancer therapies.
- International expansion: Countries with no biosimilar regulations represent growth avenues.
Conclusion
NDC 51407-0735, as a biosimilar trastuzumab, operates in a highly competitive, cost-sensitive market. Prices have decreased markedly since launch, following a trend of 15-30% discounts relative to the reference product. Over the next five years, prices are projected to decline steadily in the U.S. and internationally, influenced by increased biosimilar penetration, regulatory policies, and healthcare budget pressures.
Key Takeaways
- The biosimilar market for trastuzumab is mature, with US prices averaging below $50,000 per year.
- Competition is intensifying, leading to further price declines.
- Market expansion into emerging regions presents revenue opportunities despite price reductions.
- Regulatory environment and payer policies influence pricing and adoption strategies.
- Volume growth driven by expanded indications and demographic trends will shape revenue potential.
FAQs
Q1: How much is the average price of biosimilar trastuzumab today?
A: Between $45,000 and $55,000 annually per patient in the U.S.
Q2: What factors most influence price declines for biosimilars?
A: Market competition, payer negotiations, regulatory approvals, and manufacturing costs.
Q3: Are biosimilar prices projected to stabilize soon?
A: Prices are expected to decline modestly over the next five years before stabilizing as market saturation occurs.
Q4: Which regions are most aggressive in biosimilar adoption?
A: The European Union and the United States lead in biosimilar uptake, with Asia-Pacific showing rapid growth.
Q5: What is the primary driver sustaining biosimilar market growth?
A: Cost savings for healthcare systems while maintaining therapeutic efficacy.
References
- IQVIA. (2022). Global Oncology Market Data.
- FDA. (2018). Approval of Herzuma (trastuzumab-pkrb). Retrieved from https://www.fda.gov
- EvaluatePharma. (2022). Biosimilar Market Trends.
- Ahuja, N. (2021). Biosimilars in Oncology. Journal of Clinical Oncology, 39(25), 2774-2782.
- Centers for Medicare & Medicaid Services. (2022). Biosimilar Reimbursement Policies.
