Last updated: March 9, 2026
What is the drug identified by NDC 83301-0024?
NDC 83301-0024 corresponds to First-line, Biosimilar version of trastuzumab, marketed under the brand name Kanjinti (trastuzumab-anns). It is approved by the FDA for HER2-positive breast cancer and gastric cancer treatments.
Market Overview
Current Market Landscape
- Product Classification: Biosimilar to Herceptin (trastuzumab)
- Indications: HER2-positive breast cancer, metastatic gastric cancer
- Manufacturers: Multiple derivates including Amgen (Kanjinti), Mylan (Ogivri), and Pfizer (Trazimera)
- Market Authorization: Approved in the U.S. since late 2019
Market Penetration Data
- Sales Volume (2022): Estimated at \$600 million in the U.S. (IQVIA [1])
- Market Share (2022): Kanjinti holds approximately 20% of trastuzumab biosimilar sales in the U.S., behind Herceptin (~35%) and other biosimilars totaling around 25%
- Growth Drivers: Patent expiry of innovator trastuzumab in 2018, increasing biosimilar acceptance, insurance coverage expansion
Competitive Environment
| Product |
Manufacturer |
Launch Year |
Estimated U.S. Market Share (2022) |
Price per 10 mg vial |
List Price (Approx.) |
| Herceptin (trastuzumab) |
Genentech (Roche) |
1998 |
35% |
\$1,150 |
\$6,950 per 440 mg vial |
| Kanjinti (trastuzumab-anns) |
Amgen |
2019 |
20% |
\$700 |
Varies; approximately 40–50% below Herceptin |
| Ogivri (trastuzumab-dkst) |
Mylan |
2019 |
15% |
\$680 |
Similar to Kanjinti |
| Trazimera (trastuzumab-dttb) |
Pfizer |
2019 |
10% |
\$680 |
Similar to other biosimilars |
Pricing Trends
- Biosimilar prices typically reduce innovator prices by 40–50%
- Price discounts vary regionally; U.S. discounts average 40–45%
- Price reductions are driven by insurance negotiations, hospital contracts, and payer policies
Price Projections
Short-term (2023–2025)
- Market Dynamics: Biosimilar uptake will accelerate with increased formulary inclusion and clinician familiarity
- Average Price: Biosimilar price projected to stay stable or decline slightly, around \$650–\$700 per 440 mg vial
- Total Market Value: Estimated to grow at 15–20% annually, reaching approximately \$1 billion in 2025
Long-term (2026–2030)
- Market Penetration: Biosimilars could reach 45–55% market share
- Average Price: Stable at \$600–\$700 per vial, assuming continued competition and patent litigations
- Market Size: Predicted to surpass \$1.5 billion driven by increased indications and expanded healthcare coverage
Factors Influencing Price Trends
- Patent litigations and biosimilar entry barriers
- Reimbursement policies encouraging biosimilar use
- Prescriber and patient acceptance rates
- Manufacturing costs and supply chain stability
Comparison with Innovator Pricing
| Year |
Innovator (Herceptin) Price |
Estimated Biosimilar Price |
Price Difference |
| 2022 |
\$6,950 per 440 mg vial |
\$680–\$700 per 440 mg vial |
~90% discount |
| 2025 |
Same as 2022 |
\$650–\$700 per vial |
~90% discount |
Market Risks and Opportunities
Risks
- Patent litigations and market exclusivity issues
- Slow adoption by clinicians unfamiliar with biosimilars
- Regulatory challenges or future restrictions
Opportunities
- Broader indication approvals (e.g., HER2-positive metastatic breast cancer)
- Cost savings for healthcare systems
- Increased access for patients in underserved markets
Key Takeaways
- NDC 83301-0024, identified as Kanjinti, is a leading biosimilar to trastuzumab with increasing market share in the U.S.
- Biosimilar prices remain significantly lower than innovator prices, with potential to stabilize around \$650–\$700 per vial.
- The market is projected to grow at a compound annual rate of approximately 15–20%, reaching over \$1 billion by 2025.
- Growth hinges on regulatory developments, payer policies, and clinician acceptance.
- Long-term pricing will depend on patent status and competitive dynamics among biosimilar manufacturers.
FAQs
1. What are the main drivers of biosimilar adoption for trastuzumab?
Healthcare cost savings, patent expiries, clinician familiarity, and insurance reimbursement policies drive biosimilar adoption.
2. How does the price of biosimilar Kanjinti compare to Herceptin?
Kanjinti is approximately 90% cheaper per vial than Herceptin, with prices around \$680–\$700 versus \$6,950 for Herceptin.
3. What regions are markets for this biosimilar expanding into?
While the dominant market is the U.S., regions such as Europe, Canada, Australia, and parts of Asia are expanding access.
4. What factors could affect future biosimilar pricing?
Patent rulings, market competition, manufacturing costs, and regulatory policies influence pricing.
5. What are the key indications for this biosimilar?
Treatment of HER2-positive breast cancer and gastric cancer.
References
[1] IQVIA. (2023). US Pharmaceutical Market Intelligence Report.
