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Market Analysis and Price Projections for NDC 59651-0516
Last updated: February 17, 2026
What is NDC 59651-0516?
NDC 59651-0516 corresponds to a biosimilar version of trastuzumab (Herceptin) intended for the treatment of HER2-positive breast cancer, metastatic gastric cancer, and other conditions. It is marketed by Pfizer under the brand name Trazimera.
Market Position and Commercial Landscape
Product Overview
Indication: HER2-positive breast cancer, metastatic gastric, and esophageal cancers.
Type: Biosimilar to trastuzumab.
Approval: FDA approved in 2018.
Manufacture: Pfizer.
Market Share and Competitors
Biosimilar trastuzumab entered a competitive market with options including:
Herceptin (Genentech/Roche)
Kanjinti (Amgen)
Zurpretuzumab (Medytox)
Market penetration: Pfizer’s Trazimera has gained significant initial market share, particularly in the United States, driven by price competitiveness and formulary access.
Current Market Size
According to IQVIA data, the trastuzumab market in the U.S. was valued at approximately $1.8 billion in 2022.
Biosimilar uptake accounts for roughly 25-30% of trastuzumab prescriptions.
Annual growth rate for biosimilar trastuzumab sales is estimated at 15-20%.
Pricing Analysis
List and Wholesale Acquisition Cost (WAC)
Herceptin (Brand): Approximate WAC of US$ 2,960 per 440 mg dose (as of 2023).
Biosimilar (Trazimera): List price around 15-25% lower implying levels near US$ 2,200 - 2,500 per 440 mg dose.
Pricing Trends
The discounted prices for biosimilars in the U.S. typically range from 20% to 30% below the originator.
Price reductions are ongoing as biosimilar competition intensifies, with some payers pushing for further discounts or rebate agreements.
Market Entry Impact and Future Price Projections
Market Dynamics
Price Competition: Biosimilar competition continues to exert downward pressure on prices.
Payer Policies: Increased formulary adoption reduces the price advantage for biosimilars initially.
Manufacturing & Supply chain: Pfizer has established robust supply chains, supporting stable pricing.
Projection for 2024-2028
Price stabilization: Expected to remain within 10-20% below originator levels due to market saturation.
Price decline trajectory: Biosimilar prices are projected to decrease by an additional 5-10% annually, approaching US$ 2,000 per 440 mg dose.
Market share growth: Biosimilar sales are expected to account for over 50% of trastuzumab prescriptions by 2025.
Key Factors Influencing Future Prices
Regulatory approvals of new biosimilars.
Payer and formulary negotiations favoring biosimilar adoption.
Patent litigation: Patent expirations for Herceptin are largely completed, opening more biosimilar entrants.
Rebate and contracting strategies by manufacturers.
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