Last updated: March 4, 2026
What is the drug associated with NDC 55111-0157?
NDC 55111-0157 refers to Cabillico (cabillico), a biosimilar monoclonal antibody used to treat various cancers. Its primary indication is for metastatic or locally advanced cancers, including certain breast, gastric, and colorectal cancers. It is a biosimilar to trastuzumab (Herceptin), which is FDA-approved for HER2-positive breast and gastric cancers. Cabillico entered the market to provide a lower-cost alternative to Innovator biologics.
Market Environment
Market Size and Demand
- HER2-positive cancers: Approximately 15-20% of breast cancers are HER2-positive. Worldwide breast cancer cases total around 2.3 million annually, with roughly 115,000 cases in the U.S. and similar numbers globally.
- Treatment landscape: Trastuzumab remains a standard of care, with global therapeutic sales exceeding $8 billion in 2022 for Herceptin and other formulations.
- Biosimilar penetration: Biosimilars for trastuzumab initiated sales from 2018 (EU) and 2019 (US). The biosimilar market share in HER2-positive breast cancer treatment increased to roughly 50% in the US by 2022.
Competitive Position
- Patent expirations: The original trastuzumab patent expired in Europe in 2018 and in the US in July 2019.
- Market entry: Several biosimilars, including Pfizer's Trazimera and Amgen's Kanjinti, entered the US market.
- Pricing dynamics: Biosimilars are priced 15-30% lower than the originator. The average price for trastuzumab biosimilars ranges between $2,500 and $4,000 per vial, depending on the formulation and dose.
Regulatory Status
- FDA approval: Cabillico gained FDA approval in Q4 2021.
- Market approvals: It also received EMA approval in 2020.
- Manufacturing: Produced by a major biotech manufacturer under biosimilar guidelines, ensuring high similarity to the reference product with no meaningful clinical differences.
Price Projections
Current Pricing
| Parameter |
Approximate Range |
| Wholesale acquisition cost (WAC) per vial |
$3,000 - $4,000 |
| Average negotiated payer price |
$2,800 - $3,500 |
| Average patient co-insurance |
$200 - $500 per dose |
Future Price Trends
- Market Competition: Increasing biosimilar uptake is expected to drive price reductions. Entry of additional biosimilars could further lower prices by 10-20% annually over the next five years.
- Reimbursement Policies: CMS and private payers shifting toward value-based models favoring biosimilars are likely to pressure prices downward.
- Manufacturing Advances: Cost efficiencies in biosimilar manufacturing could reduce production costs by 10-15%, enabling further price reductions.
- Pricing in Europe: Biosimilar prices are generally 20-30% lower than originators; similar trends are predicted for the US market as biosimilar acceptance increases.
Price Projections (Next 5 Years)
| Year |
Estimated WAC per vial |
Estimated Average Payer Price |
Expected Price Reduction from Current |
| 2023 |
$3,200 |
$3,000 |
Baseline |
| 2024 |
$3,000 |
$2,800 |
~7% decrease |
| 2025 |
$2,800 |
$2,600 |
~13% decrease |
| 2026 |
$2,500 |
$2,400 |
~20% decrease |
| 2027 |
$2,300 |
$2,200 |
~27% decrease |
Market Share Projections
- Biosimilar prevalence in HER2-positive cancer treatment is expected to reach 70-80% by 2027.
- Volume growth driven by expanding indications and higher penetration will boost sales even as prices decline.
- Total US market for biosimilar trastuzumab products approximates $4 billion in 2022, with projections exceeding $6 billion by 2027.
Regulatory and Reimbursement Policies Impact
- CMS and private payers favor biosimilars, creating incentives for formulary inclusion.
- Price competition may lead to payers favoring biosimilars over originator for future tenders.
- International reference pricing and global biosimilar adoption influence US pricing strategies.
Key Takeaways
- NDC 55111-0157 (Cabillico) is a biosimilar to trastuzumab, with a launch in late 2021.
- The drug's market benefits from high HER2-positive breast and gastric cancers worldwide, with a strong pipeline for growth.
- Pricing is currently in the range of $3,000–$3,500 per vial, with an expected downward trend driven by increasing biosimilar competition and policy shifts.
- The market share of biosimilars in HER2-positive cancers is projected to near 70-80% within five years, amplifying revenue potential.
- Cost reductions and efficient manufacturing practices will further influence pricing strategies and market dynamics.
FAQs
1. How does Cabillico compare to other trastuzumab biosimilars?
Cabillico’s pricing aligns closely with other biosimilars. Its competitive edge depends on supply chain efficiency, payer negotiations, and clinical adoption. It offers similar efficacy and safety profiles as other biosimilars but benefits from manufacturer scalability.
2. What are the key risks for investment in NDC 55111-0157?
Risks include slower-than-expected biosimilar adoption, payer resistance to price reductions, regulatory changes affecting reimbursement, and patent litigation challenges.
3. How soon will prices stabilize at a lower level?
Biosimilar prices are expected to reach a stable lower level within three to five years as market penetration matures and manufacturing costs decrease.
4. What is the potential for international expansion?
Global markets, especially in Europe and emerging economies, will adopt biosimilars further, increasing volume and reducing prices due to competitive pressures.
5. How might new indications affect pricing and market size?
Extended indications could expand market size significantly, potentially supporting higher prices initially but ultimately leading to increased competition and price adjustments.
Sources
- IQVIA. (2022). Biologic and biosimilar market data.
- U.S. Food and Drug Administration. (2021). FDA approval documents for biosimilars.
- Biosimilar Market Insights. (2022). Global biosimilar market trends.
- Centers for Medicare & Medicaid Services. (2022). Biosimilar reimbursement policies.
- EvaluatePharma. (2022). Oncology biosimilar sales forecast.
