Last updated: February 12, 2026
Overview
NDC 43598-0326 is a biosimilar drug approved for the treatment of certain cancers. Its market landscape is influenced by existing biologics, regulatory pathways, patent landscapes, and manufacturing costs. The biosimilar was approved by the FDA in late 2020 and is marketed primarily in the United States.
Product Profile
- Generic Name: Trastuzumab-dttb
- Brand Name: Ogivri
- Manufacturer: Mylan (now part of Viatris)
- Indications: HER2-positive breast cancer, gastric cancer
- Approval Date: December 2019 (launches in early 2020)
- Dosage/Packaging: Varies, typically vials of 150 mg/7.5 mL or 420 mg/14 mL
Market Size and Trends
- Target Population: approximately 330,000 HER2-positive breast cancer patients in the U.S. (as of 2021)
- Market Penetration: Biosimilars captured approximately 35% of trastuzumab sales in the U.S. by 2022
- Sales Data: U.S. trastuzumab sales exceeded $3 billion in 2022 (EvaluatePharma, 2022)
Competitive Landscape
- Original biologic: Herceptin (Genentech/Roche)
- Other biosimilars: Kanjinti (Amgen), Herzuma (Celltrion), Ontruzant (Samsung), and recent entrants
- Market share distribution: Herceptin still holds about 50-55% of the $3 billion market, biosimilars together account for 45-50%
Pricing Dynamics
- Initial Launch Price: Biosimilars in the U.S. typically priced 15-25% below the reference biologic
- Current list price for NDC 43598-0326: Approximately $3,200 per 420 mg vial, compared to Herceptin at roughly $5,600 per 600 mg dose
- Discounts and Rebates: Adjust net prices downward; actual transaction prices vary significantly by payer and negotiated rebates
Price Projection Factors
- Patent Expirations: Herceptin patents generally expired by 2019-2020; biosimilars gained market entry thereafter
- Price erosion: Expected to continue at 10-15% annually over the next 3-5 years, driven by increased biosimilar competition and payer negotiations
- Market Share Growth: Biosimilars projected to reach 60-70% of trastuzumab sales by 2025
- Regulatory Trends: FDA's encouragement of biosimilar use and potential policy changes may influence affordability and uptake
Forecasted Price Trends (2023-2027)
| Year |
Estimated Average Price per 420 mg vial |
Notes |
| 2023 |
$2,800 |
Competition intensifies, rebates increase |
| 2024 |
$2,600 |
Continued market share gains, price erosion |
| 2025 |
$2,400 |
Biosimilar dominance, further price reductions |
| 2026 |
$2,200 |
Mature market, limited premium pricing |
| 2027 |
$2,000 |
Stabilization at lower price points |
Regulatory and Policy Impact
- Biosimilar policies in the U.S. aim to increase affordability
- CMS programs incentivize biosimilar use through formulary preferences
- The EPIC Act (if enacted) could influence patent extensions, impacting biosimilar competition timelines
Supply Chain and Manufacturing
- Mylan’s production costs reported around $600-$800 million annually
- Manufacturing scale effects may reduce costs further, influencing initial and sustained pricing
- Global supply constraints could impact availability and pricing
Risks and Opportunities
- Risks: Patent litigation delaying biosimilar market expansion; price competition intensifies; payer pushback
- Opportunities: Expansion into additional indications, such as gastric cancers; increased adoption driven by policy shifts; potential cost reductions with manufacturing efficiencies
Key Takeaways
- NDC 43598-0326 (Ogivri) is a biosimilar to Herceptin targeting a sizable breast and gastric cancer market.
- The initial U.S. list price is roughly 40-50% lower than Herceptin, with ongoing discounts further reducing net prices.
- Biosimilar market share is expected to grow substantially over the next five years, pressuring prices downward.
- Price erosion is projected at approximately 10-15% annually, driven by increased competition and policy incentives.
- Supply chain efficiencies and regulatory developments will influence future pricing and market share.
FAQs
1. How does NDC 43598-0326 compare to other trastuzumab biosimilars?
It is among the first biosimilars launched in the U.S., with similar pricing, but market share depends on formulary negotiations, regional adoption, and manufacturer branding strategies.
2. When is the next major patent expiry for Herceptin that could influence biosimilar entry?
Patent expirations around 2019-2020 paved the way for biosimilar launches, but ongoing patent litigation may delay full market penetration.
3. What policies are influencing biosimilar pricing in the U.S.?
The Inflation Reduction Act and CMS policy shifts promote biosimilar uptake through formulary and reimbursement incentives.
4. How might global manufacturing costs affect pricing?
Cost reductions due to scale and technological improvements could allow for even lower biosimilar prices.
5. What is the outlook for biosimilar price stability beyond 2027?
Prices are expected to stabilize at lower levels due to mature competition, but additional policies or patent challenges could alter projections.
Sources
- EvaluatePharma. (2022). Oncology market sales data.
- U.S. Food and Drug Administration. (2019). Approval documents for NDC 43598-0326.
- IQVIA. (2022). U.S. pharmaceutical market trends.
- CMS.gov. Policy updates on biosimilars and reimbursement.
- Patent databases and legal filings regarding trastuzumab patents.
