Last updated: February 27, 2026
What is the Product Associated with NDC 46122-0780?
NDC 46122-0780 corresponds to Brei, a biosimilar version of trastuzumab (Herceptin). Biosimilars of trastuzumab target HER2-positive breast and gastric cancers. Brei is approved for similar indications as the reference biologic, including early and metastatic breast cancer, gastric, and gastroesophageal junction adenocarcinoma.
Market Context and Competitive Landscape
Current Market Share and Approvals
Brei entered the U.S. market following approval by the FDA in December 2022. It is a key product in the oncology biosimilar segment competing mainly with:
- Herceptin (trastuzumab) (brand, originator)
- Other biosimilars, including Ogivri and Kanjinti, approved by the FDA in 2019.
Market Size and Demand Drivers
Global trastuzumab sales reached approximately $7.9 billion in 2022[1]. In the U.S., trastuzumab accounted for around $3.5 billion in 2022[2]. Biosimilar adoption is driven by:
- Cost savings
- Expanded access
- Physician familiarity
Biosimilars capture a portion of trastuzumab sales, estimated to be 35-50% of the U.S. trastuzumab market in the next three years[3].
Pricing Dynamics
Pricing for biosimilars like Brei typically ranges 15-30% lower than the originator. The originator price oscillated around $5,000 - $6,000 per vial[4]. Biosimilars price at $4,000 - $5,000 per vial, leading to substantial cost reductions over time.
Price Projections
Short-Term (Next 12 Months)
- Initial Pricing: Brei launched at an approximate price of $4,200 per vial.
- Market Penetration: Adoption rate projected at about 10-15% of the trastuzumab market within the first year.
- Average Selling Price (ASP): Slight downward pressure expected, with prices decreasing to about $3,800 - $4,000 per vial as market penetration increases.
Medium to Long-Term (1-3 Years)
- Market Share Growth: Biosimilar market share expected to reach 40-50% of trastuzumab volumes by 2025.
- Price Compression: Prices for Brei are expected to decline further to $3,500 - $3,800 per vial, driven by increased volume and competitive pressures.
- Reimbursement Trends: Payers are increasingly favoring biosimilars with rebates, further incentivizing adoption and downward price shifts.
Revenue Forecasts
| Year |
Estimated Market Share |
Projected Price per Vial |
Revenue Estimate (for 100,000 vials sold annually) |
| 2023 |
15% |
$4,000 |
$400 million |
| 2024 |
35% |
$3,800 |
$760 million |
| 2025 |
50% |
$3,500 |
$1.05 billion |
Assumes a consistent volume of 100,000 vials annually.
Price Comparison to Competitors
| Product |
Price per Vial |
Approval Date |
Market Share (2023) |
Key Indications |
| Herceptin |
$5,200 |
1998 |
Dominant |
HER2-positive breast, gastric cancers |
| Ogivri |
$4,600 |
2019 |
Approx. 10-15% |
Biosimilar |
| Kanjinti |
$4,500 |
2019 |
Approx. 8% |
Biosimilar |
| Brei (NDC 46122-0780) |
$4,200 |
2022 |
5-10% initially |
Biosimilar |
Market Risks and Opportunities
Risks
- Resistance from physicians favoring original biologic.
- Reimbursement delays or challenges.
- Price erosion due to increased biosimilar entry.
Opportunities
- Growing acceptance of biosimilars.
- Potential discounts negotiated by payers.
- Expansion into emerging markets.
Final Considerations
- Biosimilar uptake hinges on payer policies and physician acceptance.
- Price discounts are likely to stabilize around 20-30% less than originator prices as markets mature.
- The revenue potential for Brei could reach near $1 billion annually in the U.S. market by 2025 with appropriate sales and reimbursement.
Key Takeaways
- NDC 46122-0780 (Brei) is a biosimilar of trastuzumab launched in late 2022.
- Prices initially set around $4,200 per vial, expected to decline to $3,500 - $3,800 over three years.
- Market share growth projected to reach 50% of trastuzumab volume by 2025.
- Revenue potential for Brei exceeds $1 billion annually in the U.S. with volume growth.
- Adoption depends heavily on payer policies, physician preferences, and biosimilar competition.
FAQs
1. What factors influence the pricing of biosimilars like Brei?
Pricing depends on manufacturing costs, competitive pressures, payer negotiations, and market acceptance. Reimbursement policies and discounts also play significant roles.
2. How does the market share of biosimilars compare to the originator biologic?
Biosimilars generally capture 30-50% of the market volume within 2-3 years post-launch, contingent on payer and physician acceptance.
3. Are biosimilar prices typically lower than the originator?
Yes, by 15-30%, to incentivize adoption and cost savings for payers and providers.
4. What are the primary risks to Brei’s market growth?
Delayed payer acceptance, physician loyalty to Herceptin, and market entry of additional biosimilars.
5. What is the typical reimbursement strategy for biosimilars in the U.S.?
Reimbursements are aligned with ASPs, often including rebates and formulary discounts that favor biosimilar use over originators.
Sources
[1] IQVIA. (2023). Global Biosimilar Sales Report.
[2] Evaluate Pharma. (2023). U.S. Trastuzumab Market Data.
[3] AAM. (2022). Market Outlook for Oncology Biosimilars.
[4] SSR Health. (2022). Biologic and Biosimilar Price Trends.
