Last updated: February 27, 2026
What Is the Drug Identified by NDC 31722-0242?
The National Drug Code (NDC) 31722-0242 corresponds to Biosimilar/Generic version of trastuzumab. Trastuzumab is a monoclonal antibody used primarily for HER2-positive breast cancer and gastric cancers. The biosimilar version offers cost-effective alternatives to brand-name medications like Herceptin.
Market Overview
Current Market Landscape
| Parameter |
Details |
| Approved indictions |
HER2-positive breast cancer, gastric cancer |
| Market size (2022) |
Estimated USD 4.2 billion globally (upward of USD 1.8B in the U.S.) |
| U.S. sales (2022) |
Approx. USD 1.2 billion |
| Patent expiring |
U.S. patent expiration around 2023-2025 — biosimilar entrants increased post-expiry |
Key Market Players
| Company |
Product Name |
Launch Date |
Market Share (estimated) |
| Pfizer |
Trazimera |
2019 |
35% |
| Amgen |
Kanjinti |
2019 |
25% |
| Samsung Bioepis |
Ontruzant |
2019 |
20% |
| Other entrants |
Less than 20% |
— |
— |
Regulatory Environment
- U.S. FDA approvals: The biosimilar was approved under the abbreviated new drug application (ANDA) pathway.
- Patent litigations/disputes: Several biosimilar manufacturers faced patent litigation delays, impacting initial market entry.
Price Trends and Projections
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per vial |
Market Penetration |
| 2019 |
USD 2,500 |
Initial launch |
| 2020 |
USD 2,300 |
Moderate decline |
| 2021 |
USD 2,200 |
Increased biosimilar uptake |
Current Pricing (2023)
| Parameter |
Value |
| Average price per 440 mg vial |
USD 2,100 |
| Discounted price (with insurance/rebates) |
USD 1,500–1,800 |
Future Projections (2024–2028)
- Prices are expected to decline further as biosimilar market share increases.
- Anticipated price per vial by 2028: USD 1,200–1,500.
- Volume sales expected to double, driven by healthcare payers favoring biosimilars over reference biologics to reduce costs.
Pricing Drivers
- Patent expirations increase biosimilar competition.
- Manufacturing efficiencies lower production costs over time.
- Payer policies favor biosimilars, offering formulary inclusions and discounts.
- Regulatory approaches facilitating biosimilar approval further push market penetration.
Market Entry and Growth Barriers
| Barrier |
Details |
| Patent Litigation |
Delay biosimilar launches, impact pricing |
| Physician Acceptance |
Some clinicians prefer reference biologic |
| Reimbursement Landscape |
Reimbursement rates influence biosimilar prescription rates |
Investment and R&D Outlook
- Biosimilar development costs: USD 100–200 million per product.
- Development timeline: 7–10 years inclusive of clinical trials.
- Patent litigations can extend time-to-market by 1–2 years.
Expected market growth of the biosimilar HER2 category: CAGR of 15-20% from 2023-2028, driven by expiry of patents and increased utilization.
Summary
| Key Point |
Data Point |
| Market size (2022) |
USD 4.2 billion, with USD 1.8 billion in the U.S. |
| Price reduction trends |
2023 average USD 2,100 per vial, declining to USD 1,200–1,500 by 2028 |
| Renegotiation opportunities |
Payers seeking biosimilar discounts |
| Market growth |
15–20% CAGR in biosimilars for HER2-targeted therapies |
Key Takeaways
- The biosimilar for trastuzumab (NDC 31722-0242) is gaining market share post-patent expiration.
- Prices are decreasing, reflecting increased biosimilar adoption.
- The market is projected to grow rapidly, with prices stabilizing at lower levels as competition intensifies.
- Patent disputes may influence launch timelines and early market prices.
- Payers and providers are increasingly incentivized to favor biosimilars, aiding sales growth.
FAQs
Q1: When will biosimilar trastuzumab be available at the lowest price?
A1: Prices are expected to approach USD 1,200–1,500 per vial by 2028, contingent on market competition and regulatory factors.
Q2: How does biosimilar approval impact market dynamics?
A2: Biosimilar approval increases competition, leading to lower prices and broader patient access, but patent litigation can delay entry.
Q3: Which companies hold the largest market share?
A3: Pfizer’s Trazimera (~35%), Amgen’s Kanjinti (~25%), and Samsung Bioepis’s Ontruzant (~20%) lead the market.
Q4: What factors influence biosimilar pricing?
A4: Patent status, manufacturing costs, payer policies, and market competition.
Q5: What are the barriers to biosimilar adoption?
A5: Physician familiarity, patent disputes, reimbursement rules, and patient/provider confidence in biosimilars.
References
- Amgen Inc. (2022). Kanjinti product information. U.S. Food and Drug Administration.
- Centers for Medicare & Medicaid Services. (2022). Biosimilar utilization and reimbursement data.
- IQVIA. (2023). Biosimilar market analysis and forecasts.
- U.S. Food and Drug Administration. (2021). BLA approvals and guidance documents.
- EvaluatePharma. (2023). Market forecasts for biosimilars in oncology.
