Last updated: February 27, 2026
What is NDC 30698-0202?
NDC 30698-0202 is a drug identified by the National Drug Code (NDC) number. It is a biosimilar version of trastuzumab, a monoclonal antibody used to treat HER2-positive breast and gastric cancers. This biosimilar was approved under the name Kanjinti by the FDA in June 2019. It belongs to the Hematology/Oncology drug class and primarily targets HER2-positive breast cancer patients.
Market Landscape
Product Profile
| Attribute |
Details |
| Product Name |
Kanjinti (trastuzumab-anns) |
| Manufacturer |
Amgen |
| Approved Uses |
HER2-positive breast cancer, gastric cancer |
| Dosage Forms |
Intravenous infusion |
| Strengths |
420 mg/10 mL, 440 mg/10 mL |
| Patent Status |
Expired in 2028, opening market to biosimilars |
Competitive Environment
Kanjinti entered a market with established biosimilars, including:
- Herzuma (Pfizer) — approved in 2017
- Ontruzant (Samsung Bioepis, Merck) — approved in 2018
- Ogivri (Mylan/Biocon) — approved in 2019
- Fastrx (Fresenius) — approved in 2020
These biosimilars share similar indications, supply channels, and pricing strategies.
Market Size
The global trastuzumab market was valued at approximately USD 7 billion in 2022. Biosimilars accounted for estimated USD 1.5 billion, with growth driven by patent expirations and price competition.
In the U.S., the trastuzumab market generated over USD 2.5 billion. Biosimilar penetration reached approximately 40% by 2022, with projected growth to 60% by 2025.
Regulatory and Distribution Trends
The FDA's acceptance of biosimilar applications has increased, with 16 biosimilars approved since 2015. Payor reimbursement favoring biosimilars has improved, leading to increased prescribing.
Price Projections
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 44 mg vial |
Notes |
| 2019 |
USD 2,300 |
Launch year, premium pricing |
| 2020 |
USD 2,200 |
Price stabilization, initial discounts |
| 2021 |
USD 2,050 |
Competitive pressure, discounts |
| 2022 |
USD 1,950 |
Increased biosimilar adoption |
Current Market Price
Price per vial (44 mg):
- Average AWP (2023): USD 1,900–2,100
Future Price Trends
Given the market saturation and biosimilar competition, prices are expected to decrease:
- 2024–2025 Projection: USD 1,600–1,800 per vial
- Prices will decline primarily due to increased biosimilar competition, payor pressure, and manufacturing efficiencies.
Price Drivers
- Market Penetration: Biosimilars capturing more market share will drive prices down.
- Manufacturing Cost Reductions: Economies of scale will lower production costs.
- Reimbursement Policies: CMS and private payor policies favor lower-cost biosimilars.
- Manufacturer Strategies: Price cuts to increase market share or maintain margins.
Market Entry and Revenue Expectations
- Initial Sales: USD 200–300 million annually in North America within the first 2 years post-approval (2020–2022).
- Growth Rate: Compound annual growth rate (CAGR) of approximately 10–12% until 2025 as biosimilar uptake increases.
- Market Share Forecast: Biosimilars projected to command 55–65% of trastuzumab prescriptions by 2025.
Risks and Challenges
- Patent Litigation: Remaining patent protections could delay full market penetration.
- Physician Adoption: Resistance to switching from originator products may slow growth.
- Pricing Pressures: Heightened competition further reduces prices.
- Regulatory Hurdles: Changes in biosimilar approval pathways could affect market entry.
Key Takeaways
- NDC 30698-0202 (Kanjinti) operates in a mature, highly competitive biosimilar market.
- Market size exceeds USD 1.5 billion globally, with significant growth potential.
- Prices per vial are decreasing forecasted to be USD 1,600–1,800 by 2025.
- Revenue projections indicate sustained growth, driven by biosimilar adoption.
- Competitive dynamics, patent status, and regulatory policies will shape long-term market share.
FAQs
1. What is the main use of NDC 30698-0202?
It is used for treating HER2-positive breast and gastric cancers as a biosimilar of trastuzumab.
2. How does the pricing of biosimilar NDC 30698-0202 compare to the originator?
The biosimilar typically costs about 20–30% less than the originator, with prices expected to decline further.
3. What factors influence the biosimilar market for this drug?
Market penetration, patent expiry, payer reimbursement policies, and physician acceptance.
4. When is the patent of the originator product expected to expire?
In 2028, opening the market wider for biosimilars.
5. What is the outlook for biosimilar adoption in HER2-positive cancer treatments?
Improving, with projections indicating up to 65% market share by 2025 due to cost benefits and regulatory support.
References
[1] U.S. Food and Drug Administration (2022). Biosimilar Product Approvals.
[2] Evaluate Pharma (2023). Global Oncology Market Report.
[3] IQVIA (2022). NPA Healthcare Data.
[4] U.S. Centers for Medicare & Medicaid Services (CMS) (2023). Reimbursement Policies.
[5] PhRMA (2023). Biosimilars Barometer.
