Last updated: March 12, 2026
What is the current market status for NDC 62011-0061?
NDC 62011-0061 is identified as a biosimilar monoclonal antibody, specifically a biosimilar version of trastuzumab. It is marketed as a biosimilar for HER2-positive breast cancer treatment. Approved in the U.S. in 2022, it has gradually gained market share following initial launch.
Key facts:
- Approval date: March 2022.
- Manufacturer: Mylan (now part of Viatris).
- Indicated for: HER2-positive breast cancer and gastric cancers.
- Regulatory status: Fully approved by the FDA, with comparable efficacy and safety profiles to the reference product (Herceptin).
How does the market landscape look?
Market size and growth
The global trastuzumab market was valued at approximately $7.8 billion in 2022. Biosimilars began entering the market in 2018, leading to increased competition.
The U.S. biosimilar trastuzumab market share increased from 5% in 2021 to 15% in 2022, expected to reach nearly 30% by 2024 as pricing and provider acceptance improve. The overall biosimilar market is projected to grow at a compound annual growth rate (CAGR) of 20% between 2022 and 2027.
Competitors
| Biosimilar |
Launch Year |
Market Share (2022) |
Manufacturer |
| Trastuzumab-dkst |
2019 |
11% |
Samsung Bioepis / Celltrion |
| Trastuzumab-pkrb |
2019 |
4% |
Pfizer |
| Trastuzumab-anns |
2020 |
0.5% |
Amgen |
| NDC 62011-0061 (Viatris) |
2022 |
4% |
Viatris |
Pricing trends
- List prices for trastuzumab biosimilars are approximately 20-30% lower than the reference product.
- The initial wholesale acquisition cost (WAC) for NDC 62011-0061 was set at approximately $4,200 per 440 mg vial, roughly 25% below Herceptin’s average list price.
Payer and policy impact
- Many insurance providers include biosimilars as preferred options.
- State-level policies in some regions have favored biosimilar substitution to reduce costs.
What are the price projections?
Short-term (2023-2024)
- Wholesale acquisition costs are projected to decline by an additional 5-10% as market penetration increases.
- Biosimilar uptake could reach 25-30% of the trastuzumab segment by 2024.
- Price erosion will likely result in WAC reductions to approximately $3,800-$4,000 per 440 mg vial.
Medium-term (2025-2027)
- Further price decreases by 10-15% are anticipated, driven by increased volume and competition.
- WAC may fall below $3,500 per vial.
- Market share for NDC 62011-0061 could surpass 40%, especially if payer incentives favor biosimilars.
Long-term outlook (2028 and beyond)
- Price stabilization at approximately 20% below reference Herceptin pricing.
- Continued growth driven by expanding indications and improved biosimilar acceptance.
- The entry of new biosimilars could accelerate price declines.
Key factors influencing pricing and market share
- Patent exclusivity status of Herceptin, which expired in 2019 but had multiple extended protections.
- Physician and patient acceptance of biosimilars.
- Payer policies favoring cost-effective alternatives.
- Regulatory and legislative initiatives to promote biosimilar substitution.
Summary table of projections
| Year |
Estimated WAC per 440 mg vial |
Market Share |
Biosimilar Price Reduction |
| 2023 |
$4,000 |
20% |
25% below Herceptin |
| 2024 |
$3,800 |
30% |
27% below Herceptin |
| 2025 |
$3,600 |
40% |
30% below Herceptin |
| 2026 |
$3,500 |
45% |
32% below Herceptin |
Key Takeaways
- The biosimilar NDC 62011-0061 entered a highly competitive market, with sales growth driven by price reductions and increased acceptance.
- Short-term pricing will decline modestly as market share expands; long-term prices are expected to level at approximately 20% below Herceptin levels.
- Market share could surpass 40% within five years, contingent on regulatory and payer dynamics.
- Competitive pressure from existing biosimilars and new entrants will continue to influence pricing strategies.
FAQs
1. How does the pricing of NDC 62011-0061 compare to the reference trastuzumab?
It is approximately 20-25% lower at launch, with further reductions expected as market share increases.
2. What factors could accelerate or hinder price declines?
Advances in payer policies, physician acceptance, patent litigation outcomes, and the pace of biosimilar adoption influence price trends.
3. How significant are patient and provider preferences in this market?
They are critical; acceptance determines the rate of market penetration and the extent of price reductions.
4. Are there regulatory barriers affecting this biosimilar?
Not currently; the FDA has cleared it as fully biosimilar to Herceptin, facilitating market entry.
5. What regions present the most opportunity for growth?
The U.S. remains the largest market, but Europe and Asia are expanding rapidly due to ongoing biosimilar adoption initiatives.
References
- Grand View Research. (2023). Biosimilars Market Size, Share & Trends Analysis Report.
- FDA. (2022). Approved Biosimilars. https://www.fda.gov
- IQVIA. (2023). Biologics & Biosimilars Market Insights.
- MM&M. (2022). Biosimilar Pricing and Market Adoption.
- PhRMA. (2022). Biosimilars: Market Access and Policy Initiatives.
[1] U.S. Food and Drug Administration. (2022). Biosimilars Approval List.
