Last updated: February 14, 2026
What is ND C 31722-0659 and its approved use?
NDC 31722-0659 is a biosimilar version of trastuzumab, marketed under the brand name of Herzuma (or other biosimilar identifiers). It is approved for HER2-positive breast cancer, metastatic or early-stage, and gastric or gastroesophageal junction cancer. The FDA approved the drug in 2018, aligning with existing trastuzumab indications.
Market Size and Demand Drivers
Primary Indications:
- HER2-positive breast cancer (early and metastatic cases)
- HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma
Sales Drivers:
- Increasing prevalence of HER2-positive cancers.
- Adoption of biosimilars driven by policy shifts encouraging cost savings.
- Expanding indications, including neoadjuvant therapy and adjuvant settings.
Market Data (2022-2025 projections):
| Parameter |
2022 |
2023 |
2024 |
2025 |
| Estimated global market size |
$4.8 billion |
$5.2 billion |
$5.7 billion |
$6.2 billion |
| HER2-positive breast cancer segment |
$3.0 billion |
$3.2 billion |
$3.5 billion |
$3.8 billion |
| Biosimilar market penetration |
45% |
55% |
65% |
75% |
Source: IQVIA, 2022; BI Report, 2022; Own analysis
Competitive Landscape
Major competitors include:
- Herceptin (original trastuzumab) from Roche.
- Biosimilars introduced post-2018, such as Herzuma (Celltrion), Kanjinti (Amgen), and Ontruzant (Samsung).
Biosimilars have gained rapid acceptance owing to price.
Pricing and Cost Dynamics
Brand Name (Herceptin):
- US list price (2018): approximately $70,000 per 10-vial pack (~600 mg/vial).
- Discounted to payers: $55,000-$60,000, factoring rebates and discounts.
Biosimilar (NDC 31722-0659):
- Entry Price (2022): approximately 20–35% lower than brand.
- Approximate wholesale acquisition cost (WAC): $45,000-$50,000 per 600 mg dose.
Price trends: Prices for biosimilars tend to decline 10–15% annually as market penetration deepens, subject to negotiations, rebate strategies, and formularies.
Market Penetration and Pricing Projections
| Year |
Estimated Biosimilar Market Share |
Expected Average Price (per 600 mg dose) |
Comments |
| 2023 |
55% |
$45,000-$50,000 |
Significant uptake, price discount persists |
| 2024 |
65% |
$40,000-$45,000 |
Price reductions continue, increased competition |
| 2025 |
75% |
$35,000-$40,000 |
Market stabilizes around these levels |
Key influences on pricing:
- Payer negotiations favor lower prices.
- Patent expiry of original biologics catalyzes biosimilar acceptance.
- Legislative and policy initiatives support biosimilar adoption.
- Supply chain dynamics and manufacturing costs also impact prices.
Summary of Key Takeaways
- NDC 31722-0659 is positioned in a growing global HER2-positive cancer market.
- Biosimilar has gained significant market share, with price discounts leading to substantial cost savings.
- The price projection indicates a declining trend, with a possible price of $35,000–$40,000 per 600 mg dose in 2025.
- Competitive pressure and payer strategies will influence future pricing, with continued market penetration driving down costs.
Five FAQs
1. How does NDC 31722-0659 compare to the original trastuzumab in price?
It is generally 20-35% less expensive at launch, with prices expected to decline further as market penetration grows.
2. What factors will influence the future price of this biosimilar?
Market competition, payer negotiations, patent expirations, and supply chain costs.
3. What is the scope of global adoption for this biosimilar?
Adoption is expanding rapidly worldwide, particularly in countries with policies favoring biosimilar substitution to reduce healthcare costs.
4. How does biosimilar efficacy compare to the original biologic?
Regulatory approval confirms biosimilar efficacy and safety are equivalent to trastuzumab for approved indications.
5. When will biosimilar market share reach 75%?
Projected around 2025, assuming continued policy support and market acceptance.
Sources
[1] IQVIA Institute for Human Data Science, 2022.
[2] BI Report, 2022.
[3] FDA Approval Documentation, 2018.
