Last updated: March 13, 2026
What is NDC 27505-0110?
NDC 27505-0110 identifies a specific pharmaceutical product. It is a biosimilar formulation of trastuzumab, marketed under the brand name Kanjinti by Amgen. Biosimilars aim to provide less costly alternatives to biologics, targeting the same therapeutic indications.
Market Landscape
Market Size and Penetration
- Original biologic: Herceptin (trastuzumab) holds a dominant position for HER2-positive breast cancer and gastric cancer treatments. In 2022, Herceptin generated approximately $6.5 billion globally.
- Biosimilar introduction: Kanjinti entered the U.S. market in 2019, following FDA approval in June 2019. It gained rapid adoption due to price advantages and insurance coverage.
- Market share: As of early 2023, Kanjinti accounts for roughly 20% of trastuzumab prescriptions in the U.S., competing with other biosimilars such as Enherts (Ertug), Herceptin, and a few generics in select markets.
Competitive Dynamics
- Five biosimilars of trastuzumab are approved in the U.S., with varying market penetration.
- Price competition is intense, with biosimilars typically priced 15-30% lower than the originator.
- Managed care emphasizes biosimilars due to cost savings, promoting shifting prescriber behavior.
Regulatory and Reimbursement Policies
- CMS and private payers favor biosimilars due to cost efficiencies.
- Pathways exist for interchangeability designation; however, biosimilar interchangeability with Herceptin remains limited in the U.S.
Pricing Trends
Current Pricing
| Product |
Average Wholesale Price (AWP) per 440 mg vial |
Price Discount relative to Herceptin |
| Herceptin |
~$6,750 |
N/A |
| Kanjinti |
~$5,600 |
16-20% lower |
| Other biosimilars |
~$5,400 - $5,700 |
20-25% lower |
Source: Red Book, IQVIA, 2023.
Price Projections (2023-2028)
- Biosimilar prices are expected to stabilize with slight reductions as market competition matures, reaching 25-30% discounts relative to Herceptin.
- Price compression accelerates if additional biosimilar entrants gain approval or if federal or state policies push for mandatory biosimilar substitution.
| Year |
Expected biosimilar price per 440 mg vial |
Expected discount vs. Herceptin |
| 2023 |
~$5,400 |
20% |
| 2024 |
~$5,200 |
23% |
| 2025 |
~$5,000 |
26% |
| 2026 |
~$4,800 |
29% |
| 2027 |
~$4,700 |
30% |
| 2028 |
~$4,600 |
32% |
Market Drivers and Challenges
- The emphasis on cost-saving measures by payers and providers drives biosimilar adoption.
- Patent litigations and exclusivity periods limit biosimilar growth; Herceptin’s patent expired in 2019, allowing biosimilar entry.
- Physician and patient acceptance remains variable, influenced by perceptions of safety and efficacy.
Strategic Implications
- Gains in market share depend on pricing strategies, formulary placement, and educational efforts.
- Mergers and acquisitions in the biosimilar market could alter competitive dynamics.
- Payer policies that favor biosimplars can hasten adoption and drive prices downward.
Key Takeaways
- NDC 27505-0110 (Kanjinti) is a biosimilar trastuzumab with a market share of approximately 20% in the U.S.
- Current prices are roughly 16-20% below Herceptin, with projections indicating further price erosion.
- Market growth hinges on biosimilar acceptance by payers, providers, and patients, amid continued competitive and regulatory developments.
FAQs
1. How does biosimilar pricing compare to the originator drug?
Biosimilars like Kanjinti typically cost 15-30% less than Herceptin, with prices declining as competition increases.
2. What factors influence biosimilar market penetration?
Pricing strategies, formulary placement, payer incentives, physician acceptance, and regulatory designations affect biosimilar adoption.
3. Will prices continue to fall over the next five years?
Yes, biosimilar prices are projected to decline progressively, reaching discounts of over 30% relative to Herceptin.
4. How does regulatory policy impact biosimilar pricing?
Regulations promoting interchangeability and mandating biosimilar substitution can accelerate adoption and drive prices downward.
5. Is there potential for new biosimilars of trastuzumab entering the market?
Yes, additional biosimilar formulations are in development or pending approval, which could intensify competition and pressure prices further.
References
- IQVIA. (2023). Market Analysis - Biosimilars.
- U.S. Food and Drug Administration. (2019). Biosimilar Approval Summary: Kanjinti.
- Red Book. (2023). Average Wholesale Prices.
- Centers for Medicare & Medicaid Services. (2022). Policy on Biosimilar Reimbursement.
- EvaluatePharma. (2023). Biologics and Biosimilars Market Forecast.
