Last updated: February 13, 2026
Overview
NDC 24208-0508 is a biologic drug marketed by Amgen, primarily used for the treatment of metastatic colorectal cancer and other indications involving HER2-positive tumors. The medication is a monoclonal antibody with a complex biosimilar and patent landscape impacting market access and pricing.
Market Landscape
Indications and Usage
- Approved for HER2-positive metastatic breast cancer, gastric, and gastroesophageal tumors.
- Also used for certain cases of metastatic colorectal cancer with HER2 amplification or overexpression, under specific regulatory contexts.
Market Size
- The global HER2-targeted therapy market was valued at approximately $8 billion in 2022.
- The growth rate (CAGR) projected at around 8% through 2027, driven by expanding indications and increasing adoption.
- In the U.S., the colorectal cancer segment accounts for roughly 20% of the HER2-positive tumor treatment market.
Key Competitors
| Drug/Entity |
Indications |
Estimated Market Share (2022) |
Price Range (per dose) |
| Trastuzumab (Herceptin) |
Breast, gastric |
60% |
$1,800 - $3,000 |
| Pertuzumab (Perjeta) |
Breast, gastric |
25% |
$2,100 - $3,200 |
| Tucatinib (TUKYSA) |
Breast |
10% |
$9,500 (monthly kit) |
| Biosimilar versions of trastuzumab |
Breast, gastric |
5% |
25-40% lower than originator |
Patent and Biosimilar Landscape
- Original patent protections for trastuzumab expired in the U.S. in 2019, leading to biosimilar entry.
- No biosimilar approvals for NDC 24208-0508 currently observed; potential for biosimilar development exists.
- Patent litigation and exclusivity periods may sustain pricing power until 2025-2028.
Price Projections
Current Pricing Dynamics
- Price per dose in the U.S. ranges from $1,800 to $3,000 depending on dosage and indication.
- Commercial contracts and rebates influence net prices, with actual patient cost substantially lower due to insurance coverage.
Future Price Trends (2023-2028)
- Short term (2023-2024): Prices are expected to stabilize due to limited biosimilar competition. List prices will likely remain within current ranges.
- Medium term (2025-2026): Introduction of biosimilars targeting NDC 24208-0508 expected to exert downward pressure. Biosimilar adoption could reduce list prices by 25-40%.
- Long term (2027-2028): Biosimilar penetration reaches 60-70%, reducing the original drug's market share and average price. Expect list prices to decline by approximately 30-50% from current levels.
Pricing Considerations
- The degree of biosimilar market penetration and payor negotiations will strongly influence net prices.
- Economic incentives for hospitals and providers to prefer biosimilars could accelerate price reductions.
- Regulatory changes and patent expiry dates are critical factors influencing pricing trajectories.
Market Risks and Opportunities
Risks
- Patent litigations delaying biosimilar market entry.
- Physicians preferring originator biologics due to familiarity and perceived efficacy.
- Shifts in regulatory policies affecting biosimilar substitution.
Opportunities
- Early biosimilar approval could capture market share and lower prices.
- Expanding indications, such as colorectal cancer, can increase volume.
- Strategic alliances with payors to improve formulary positioning.
Summary
- NDC 24208-0508 is a high-value biologic within a competitive HER2-targeted therapy market.
- Current U.S. list prices range from $1,800 to $3,000 per dose.
- Biosimilar competition is poised to significantly influence pricing after 2024, with potential reductions of 25-50% over the next 3-5 years.
- Market growth is driven by expanding indications and increased adoption, but patent protections and biosimilar entry remain primary determinants of future price movements.
Key Takeaways
- Until biosimilars enter the market, prices are likely to remain stable.
- Entry of biosimilars could lead to substantial price reductions.
- Market growth potential depends largely on regulatory approval timelines and physician adoption.
- The market is susceptible to patent litigation delaying biosimilar launches.
- Payor strategies and formulary influences will shape net prices more than list prices.
FAQs
1. When can biosimilars for NDC 24208-0508 be expected?
Potential approval may occur between 2024 and 2026, contingent upon patent expiration and ongoing regulatory reviews.
2. How does patent expiry impact pricing?
Patent expiry allows biosimilar market entry, which reduces prices through increased competition.
3. What factors influence the adoption of biosimilars?
Physician acceptance, payor rebates, regulatory policies, and formulary preferences.
4. Are there regional differences in pricing?
Yes. European markets tend to negotiate lower prices than the U.S., influenced by local health authorities and regulatory environments.
5. What other therapies might impact this market?
New targeted therapies and immunotherapies for HER2-positive cancers could shift market shares away from NDC 24208-0508.
Citations
[1] Market data sourced from Statista and EvaluatePharma (2022).
[2] Patent and biosimilar landscape details from FDA and EMA reports (2023).
