Last updated: February 13, 2026
Overview
NDC 51407-0278 is a biosimilar version of trastuzumab, marketed by Henry Schein under the brand name HERZUMA. Originally developed for breast and gastric cancers, trastuzumab biosimilars have gained market traction due to patent expirations and pricing pressures.
Market Status
As of 2023, the biosimilar sector for trastuzumab mainly includes:
- Herzuma (Henry Schein), approved in 2019.
- Ogivri (Mylan/Biocon), approved in 2017.
- Kanjinti (Amgen), approved in 2019.
- Ontruzant (Samsung Bioepis), approved in 2017.
Market penetration of HERZUMA remains moderate, largely confined to specific healthcare settings due to physician prescribing habits, insurance coverage, and availability. The drug's primary competitors include originator Herceptin (Genentech).
Market Size
The global trastuzumab market was valued around $6 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of approximately 8% through 2028. Biosimilar uptake varies by region, with North America representing roughly 45% of the market, driven by high drug prices and shifting insurance reimbursement policies.
In the U.S., trastuzumab sales approached $2.5 billion in 2022. Biosimilar versions captured approximately 25–30% of this segment due to delayed adoption phases.
Pricing Trends
Initial Biosimilar Pricing (2019–2021):
- Release prices for trastuzumab biosimilars ranged from 15% to 30% below the originator.
- HERZUMA's average wholesale price (AWP) was approximately $2,100 per 440 mg vial, compared to Herceptin’s $2,600–$2,900.
- Contractual discounts lowered patient out-of-pocket costs for hospitals and payers.
Current Price Projections (2023–2028):
- Biosimilar prices are expected to decrease by 10–15% annually as more competitors enter and formulary restrictions tighten.
- The projected AWP for HERZUMA in 2025 could be approximately $1,800–$2,000 per 440 mg vial, a decrease of around 25–30% from initial launch prices.
- The price gap between HERZUMA and both the reference product and other biosimilars will continue to narrow.
Market Drivers & Barriers
- Drivers: Cost containment pressures, expanding indications, improved biosimilar acceptance by clinicians, and evolving payer policies favoring biosimilar substitution.
- Barriers: Physician hesitancy, supply chain fragmentation, and legal/patent disputes delaying biosimilar adoption.
Regulatory and Patent Landscape
- The original Herceptin patent expired in the U.S. as of 2019.
- Biosimilar approvals depend on demonstrating biosimilarity and immunogenicity profiles.
- Patent litigations continue around certain formulations, potentially affecting supply and pricing.
Future Market Outlook
- Biosimilar trastuzumab sales are forecast to dominate the U.S. market by 2026, reaching nearly 40–50% of the total trastuzumab sales.
- Price reductions will stabilize as the biosimilar market matures and more competitors enter.
- New indications and combination therapies could bolster overall market size.
Summary
The drug associated with NDC 51407-0278, HERZUMA, is part of a growing biosimilar segment in the trastuzumab market. Prices are declining steadily, with projected reductions of 25–30% over the next two years. Market penetration remains moderate but is set to increase as payer policies and clinical familiarity evolve.
Key Takeaways
- HERZUMA competes primarily with other biosimilars and the originator Herceptin.
- Treated as a cost-effective alternative, biosimilar prices are expected to decrease further.
- The U.S. biosimilar market for trastuzumab is expected to capture a significant share in the next three years.
- Price projections indicate a stabilization around $1,800–$2,000 per vial by 2025.
- Market growth will depend on regulatory approvals, patent litigations, and clinician acceptance.
FAQs
1. How does the pricing of HERZUMA compare to Herceptin?
HERZUMA typically lists 15–20% lower than Herceptin’s average wholesale price, with actual discounts in purchase agreements often exceeding this.
2. What factors influence biosimilar market penetration?
Physician prescribing behaviors, insurance reimbursement policies, supply chain availability, and legal precedents impact adoption rates.
3. Are biosimilar prices expected to decrease further?
Yes, projections indicate an annual decrease of 10–15% through 2025 due to increasing competition and market maturation.
4. How significant is HERZUMA’s market share?
HERZUMA holds an estimated 10–15% of the U.S. biosimilar trastuzumab market, with potential to grow based on pricing and formulary shifts.
5. When are additional biosimilars for trastuzumab expected to enter the U.S. market?
Additional biosimilars are anticipated to gain approval between 2024 and 2026, further intensifying price competition.
Citations
[1] IQVIA, "U.S. Biosimilar Market Reports," 2022.
[2] FDA, "Biosimilar Approvals & Regulatory Updates," 2023.
[3] MarketWatch, "Global Biosimilar Market Size & Forecast," 2022.
