Last updated: March 7, 2026
What is the Drug Associated with NDC 55150-0233?
NDC 55150-0233 corresponds to a biosimilar version of trastuzumab, marketed under trade names such as Ontruzant. It is indicated for HER2-positive breast cancer, HER2-positive metastatic gastric or gastroesophageal junction carcinoma, and other HER2-related cancers.
Market Size and Growth Drivers
Current Market Tenure
The global trastuzumab market was valued at approximately USD 7.2 billion in 2022. The biosimilars segment accounted for about USD 620 million in 2022, with growth projected at 14% CAGR through 2027[1].
Key Growth Factors
- Expiration of patent exclusivity for originator products like Herceptin (2019 in the U.S.)
- Increasing approval and availability of biosimilars
- Rising incidence of HER2-positive cancers globally
- Cost reduction incentives by payers and health systems
Market Penetration
Biosimilar trastuzumab products have achieved 15-20% market share in North America and Europe, with faster uptake in markets such as India and South Korea due to cost considerations.
Price Dynamics and Competitive Landscape
Pricing Benchmarks
- Originator trastuzumab (Herceptin): List price in the U.S. $6,877 per 440 mg-vial[2].
- Biosimilar trastuzumab: Ranges from $3,900 to $5,500 per 440 mg-vial, representing a 20-40% discount.
Price Projection for NDC 55150-0233
- Initial Launch (Year 1): Approximately $4,200 to $4,700 per 440 mg vial, aligning with early biosimilar pricing strategies.
- Mid Term (Year 3): Anticipated to fall to $3,900-$4,200 as market competition intensifies.
- Long Term (Year 5): Potentially below $3,500 per vial, driven by increased biosimilar offerings and payer negotiations.
Pricing Comparison Chart
| Year |
Estimated Price per 440 mg vial |
Market Share |
Revenue Estimate (USD, at 100,000 vials/year) |
| Year 1 |
$4,500 |
10% |
$450 million |
| Year 3 |
$4,000 |
25% |
$1 billion |
| Year 5 |
$3,500 |
50% |
$1.75 billion |
Regulatory and Policy Influences
- US FDA approved the biosimilar of trastuzumab in 2017.
- CMS includes biosimilar trastuzumab in Medicare Part B, incentivizing adoption.
- European Medicines Agency approvals provide earlier access and influence pricing strategies in international markets.
- States with biosimilar substitution laws accelerate uptake, affecting pricing and revenue.
Competitive Landscape
Major Biosimilar Players
- Pfizer (Ontruzant)
- Celltrion (Herzuma)
- Samsung Bioepis (Ontruzant)
- Amgen (MUBRIT)
- Coherus (Ujenda)
Market Share Distribution
Pfizer's Ontruzant holds about 45% of the biosimilar trastuzumab market within the U.S., with Celltrion and Samsung Bioepis sharing the majority of remaining share[3].
Patent Litigation and Market Entry
Patent litigations delayed some biosimilar entries; however, by 2021, biosimilar competition increased with established launches, reducing prices and expanding access.
Key Factors Impacting Price and Market Performance
- Market Competition: Increased biosimilar options drive prices downward.
- Physician and Patient Acceptance: Trust in biosimilars influences prescribing patterns.
- Reimbursement Policies: Favorable reimbursement enhances adoption rates.
- Manufacturing and Supply Chain: Capacity expansion stabilizes supply and mitigates price surges.
Conclusion
NDC 55150-0233, representing a biosimilar trastuzumab, is poised for significant market growth driven by patent expirations and cost-driven healthcare initiatives. Price projections indicate declining costs over five years, aligning with biosimilar market trends. Competition among key players will dictate price trajectories, with volume gains compensating for lower per-unit revenue.
Key Takeaways
- The biosimilar market for trastuzumab reached USD 620 million in 2022 and is growing at 14% annually.
- The initial price for NDC 55150-0233 is estimated at around USD 4,200–4,700 per 440 mg vial.
- Prices are projected to decline to below USD 3,500 per vial within five years.
- Market share is expected to increase, with revenues potentially surpassing USD 1 billion by Year 3.
- Regulatory and reimbursement policies significantly influence adoption and pricing.
FAQs
1. How does the price of biosimilar trastuzumab compare to the originator?
Biosimilars are typically priced 20-40% lower than originator products like Herceptin, with initial prices around USD 4,200–4,700 per 440 mg vial.
2. What factors will influence the future pricing of NDC 55150-0233?
Market competition, payer negotiations, regulatory policies, and physician acceptance will drive future pricing trends.
3. Which companies dominate the biosimilar trastuzumab market?
Pfizer, Celltrion, and Samsung Bioepis are the leading producers, holding the majority market shares.
4. How might patent litigation affect the market?
Litigation delays market entries, but resolutions and patent expirations have already increased biosimilar availability.
5. What role do reimbursement policies play?
Reimbursement in Medicare, Medicaid, and private plans promotes biosimilar adoption, influencing market share and pricing.
References
[1] Grand View Research. (2022). Biosimilars Market Size, Share & Trends Analysis Report.
[2] RX Savings Solutions. (2023). Trastuzumab (Herceptin) Price Data.
[3] EvaluatePharma. (2022). Biosimilar Trastuzumab Market Share and Competitive Landscape.
