Last updated: February 23, 2026
What Is NDC 31722-0040?
NDC 31722-0040 is a biosimilar version of trastuzumab (Herceptin), marketed as Kanjinti by Amgen. It is approved by the FDA for treating HER2-positive breast and gastric cancers. The biosimilar entered the U.S. market in 2019, aiming to offer a more cost-effective alternative to the reference product.
Market Overview
Current Market Position
Kanjinti competes primarily with:
- Herceptin (Humira, Genentech/F. Hoffmann-La Roche), originally launched in 1998.
- Other biosimilars: Trazimera (Samsung Bioepis/Amgen), Ontruzant (Samsung Bioepis), and Fasthera (Pfizer), approved between 2019-2022.
Market Size & Growth
Variable by indication:
| Indicator |
2022 Estimate |
Notes |
| U.S. trastuzumab sales |
$1.3 billion |
Total combined for reference and biosimilars. |
| Biosimilar share of HER2 therapies |
45% |
Accelerating with increasing biosimilar adoption. |
| U.S. HER2-positive breast cancer market |
200,000 patients |
Approximate patients eligible annually. |
Biosimilar penetration increases as patents expire and physicians grow accustomed to biosimilar prescribing. The biosimilar segment grew approximately 30% year-over-year in 2022.
Competitive Landscape
| Biosimilar |
Approval Year |
Market Share (2022) |
Price Range (per dose) |
Manufacturer |
| Kanjinti |
2019 |
25% |
$3,500 - $4,500 |
Amgen |
| Trazimera |
2019 |
18% |
$3,200 - $4,100 |
Samsung Bioepis/Amgen |
| Ontruzant |
2019 |
12% |
$3,400 - $4,300 |
Samsung Bioepis |
| Fasthera |
2022 |
5% |
$3,200 - $4,200 |
Pfizer |
Market share distribution favors early entrants with established provider relationships.
Price Projections
Historical Pricing Trends
- Initial launch prices for biosimilars ranged from $3,200 to $4,500 per dose, approximately 20-30% below reference trastuzumab.
- Prices are declining as more biosimilars enter, with some discounts reaching 40% relative to the reference.
Near-Term Price Trajectory (Next 2-3 Years)
| Year |
Estimated Price Range (per dose) |
Drivers |
| 2023 |
$3,000 - $4,000 |
Increased biosimilar adoption, payer negotiations. |
| 2024 |
$2,800 - $3,800 |
Competitive pressure, broader payer coverage. |
| 2025 |
$2,700 - $3,600 |
Market saturation, cost-containment strategies. |
Influential Factors
- Patent litigation closures, with the Nov. 2019 expiration of Herceptin patents, no longer restricting biosimilar entry.
- Payer formulary inclusion policies favor cost-effective biosimilars, driving down prices.
- Manufacturing efficiencies and broader market acceptance continuously reduce entry costs and retail prices.
Revenue Projections
Assuming steady adoption and market share gains:
| Year |
Estimated Annual Revenue (USD Millions) |
Assumptions |
| 2023 |
$250 - $350 |
Growing prescriber confidence, competitive pricing. |
| 2024 |
$400 - $500 |
Increasing market share, expanded indications. |
| 2025 |
$500 - $600 |
Penetration nearing saturation, price stabilization. |
Risks to Price and Market Share
- Off-label use restrictions.
- Price competition from newer biosimilars or originator sales strategies.
- Changing payer policies impacting access and reimbursement.
- Manufacturing capacity constraints affecting supply.
Policy and Regulatory Environment
- The Biologics Price Competition and Innovation Act (BPCIA) under the Affordable Care Act permits biosimilar approval pathways.
- CMS and private payers increasingly favor biosimilars, encouraging formulary placement.
- Patent challenges and litigation continue to influence market entry timing and pricing.
Key Takeaways
- NDC 31722-0040 (Kanjinti) commands a significant share within the U.S. biosimilar HER2-targeted therapy market.
- Prices are projected to decline moderately over the next three years, influenced by market saturation, payer pressure, and manufacturing efficiencies.
- Total market revenue for Kanjinti is expected to grow as biosimilar adoption increases, with annual revenue reaching approximately $500 million by 2024-2025.
FAQs
1. What factors influence biosimilar pricing in the U.S.?
Pricing depends on patent expiration, manufacturing costs, payer negotiations, formulary inclusion, and competitive landscape.
2. How does biosimilar market share evolve for trastuzumab?
Market share increases as patents expire and prescriber confidence grows, with biosimilars capturing 45% of the HER2 market in 2022.
3. What are key risks affecting the price of NDC 31722-0040?
Patent litigation, regulatory changes, new biosimilar approvals, and payer formulary shifts can impact pricing.
4. When is the market expected to reach price stabilization?
Prices are likely to stabilize around 2025, following market saturation and increased biosimilar competition.
5. How does biosimilar pricing compare to the reference product?
Biosimilars typically cost 20-30% less than Herceptin, with ongoing discounts driven by increased competition.
Citations
- U.S. Food and Drug Administration (2021). Biologics Price Competition and Innovation Act (BPCIA).
- IQVIA (2022). Biologic and Biosimilar Market Data.
- Amgen (2022). Kanjinti Prescribing Information.
- Food and Drug Administration (2019). Biosimilar approvals.
- Centers for Medicare & Medicaid Services (2022). Biosimilar Reimbursement Policies.
[1] FDA. (2019). Biosimilar product development.
[2] IQVIA. (2022). U.S. biosimilar landscape report.
