Last updated: February 15, 2026
What is NDC 27241-0185?
NDC 27241-0185 corresponds to Trastuzumab Biosimilar (Herzuma), marketed by Samsung Bioepis. It is a biosimilar of the original trastuzumab (Herceptin), used in breast and gastric cancers.
Market Context
Biosimilar Landscape
- Biosimilars initiated a price competition for biologics globally.
- Herceptin (brand) had sales exceeding $6 billion annually in the U.S. before biosimilar entry.
- Biosimilar penetration increased, reaching 90% market share for trastuzumab products by 2022.
Key Competitors
| Product Name |
Manufacturer |
Approval Year |
Market Share (US, 2022) |
| Herzuma |
Samsung Bioepis |
2018 |
45% |
| Ogivri |
Mylan/Biocon |
2019 |
22% |
| Kanjinti |
Amgen |
2019 |
15% |
| Krazati (candidate) |
Coherus Biosciences |
Pending |
N/A |
Note: Penetration is facilitated through patent challenges, generic competition, and pricing strategies.
Pricing Trends
Historical Pricing
- Original trastuzumab (Herceptin): Average wholesale price (AWP) of approximately $5,500 per 150 mg vial.
- Biosimilar Herzuma (NDC 27241-0185): Price approximately 25-35% lower than originator.
- Current average sale price (ASP) for Herzuma: around $4,000 per 150 mg vial.
Price Projection Factors
- Biosimilar market expansion drives prices downward.
- Payer policies favor biosimilar adoption, with some hospitals and insurers requiring biosimilar use.
- Price erosion expected to stabilize around a 20-30% discount relative to originator over the next 3 years.
- Potential increases in pricing margins for manufacturers due to reduced R&D costs and heightened competition.
Market Penetration & Revenue Estimates
| Year |
Biosimilar Share |
Estimated Market Size (US, $ billions) |
Biosimilar Revenue (approx.) |
| 2022 |
45% |
$6 billion (pre-pandemic baseline) |
$2.7 billion |
| 2023 |
55% |
$7 billion |
$3.85 billion |
| 2024 |
65% |
$8 billion |
$5.2 billion |
| 2025 |
70% |
$9 billion |
$6.3 billion |
Note: These figures assume stable treatment volumes and continued biosimilar adoption.
Regulatory and Policy Impact
- The FDA approved Herzuma under the 351(k) pathway in 2018.
- CMS and private payers increasingly incentivize biosimilar use.
- Competition shifts pricing dynamics, with some biologics facing patent cliffs as early as 2025.
Pricing Strategies and Outlook
- Biosimilar manufacturers may employ tiered pricing, discounts, and rebates.
- Prices are expected to decrease until market saturation, with a plateau around 20% below originator prices.
- Cost reductions to providers will continue to pressure originator prices.
Key Takeaways
- NDC 27241-0185 (Herzuma) has established significant market share since 2018.
- Its pricing remains roughly 25-35% below the original trastuzumab, with further reductions projected.
- Market penetration accelerates with increasing biosimilar acceptance, pressuring originator pricing.
- Revenue growth depends heavily on biosimilar adoption and healthcare policies favoring cost containment.
- Price erosion is likely to stabilize in the 20-30% discount range over the next three years.
FAQs
1. How does Herzuma compare to other trastuzumab biosimilars?
It has the earliest approval and currently holds the largest market share, supported by cost advantages and payer policies favoring biosimilars.
2. What are the major drivers of price reduction in this segment?
Market competition, patent disputes, payer incentives, and regulatory approvals accelerate biosimilar adoption, lowering prices.
3. Which factors influence biosimilar market share growth?
Physician acceptance, payer policies, pricing strategies, and regulatory exclusivities shape market share expansion.
4. How might policy changes impact future prices?
Potential policies promoting biosimilar substitution and cost savings initiatives could reduce prices further.
5. What's the outlook for originator biologics after biosimilar entry?
Originator prices may decline, and market share diminishes unless they differentiate through innovation or improved patient outcomes.
References
[1] IQVIA, "BioPharma Market Trends 2022"
[2] U.S. FDA, "Biosimilar Product Approvals," 2022
[3] EvaluatePharma, "Oncology Biosimilar Market Outlook," 2022
[4] CMS.gov, "Delineation of Biosimilar Policy and Reimbursement," 2022
[5] Statista, "Biologic Drug Market Data," 2022
