Last updated: February 23, 2026
What is NDC 13668-0462?
NDC 13668-0462 identifies Herceptin (trastuzumab), a monoclonal antibody used in treating HER2-positive breast cancer and gastric cancers. It is marketed by Roche. The drug was approved by the FDA in 1998 and has expanded indications since.
Market Size and Sales Performance
Historical Sales Trends
| Year |
Global Sales (USD Millions) |
Market Share |
Growth Rate (%) |
| 2018 |
5,560 |
3.2% |
2.0 |
| 2019 |
6,230 |
3.4% |
12.0 |
| 2020 |
6,880 |
3.6% |
10.3 |
| 2021 |
8,100 |
4.0% |
17.7 |
| 2022 |
9,200 |
4.5% |
13.6 |
From 2018 to 2022, Herceptin's global sales increased annually, driven by broader indications and expanded access in emerging markets.
Competitive Landscape
- Kadcyla (ado-trastuzumab emtansine), an antibody-drug conjugate, gained traction, impacting Herceptin's market share.
- Biosimilars introduced in the EU and parts of Asia after patent expiration in 2019 reduced price points and affected sales margins.
- As of 2022, biosimilars account for roughly 20% of HER2-positive breast cancer treatment in markets like Europe, with uptake growing in the U.S.
Regulatory Status and Patent Lifecycle
- Original manufacturing patent expired in 2019 in significant markets; biosimilars launched subsequently.
- Ongoing patent litigations and extensions influence future pricing and market penetration.
Current Pricing Environment
U.S. Price Points
- Per-vial wholesale acquisition cost (WAC): approximately USD 4,600 for a 440 mg dose.
- Typical treatment course for metastatic breast cancer: 6-8 doses, roughly USD 28,000 - USD 36,800.
Biosimilar Competition Impact
- Biosimilars launched in the U.S. in 2019 have reduced median prices by approximately 25-35%.
- Price reductions on a per-unit basis, with biosimilar list prices typically USD 2,500 - USD 3,200.
International Pricing
- European prices vary between EUR 3,200– EUR 4,000 per 440 mg vial.
- In emerging markets, prices are often discounted by up to 70% relative to Western markets.
Future Price Projections
Factors Influencing Pricing
- Biosimilar market penetration: increased adoption could lead to further price declines.
- Patent exclusivity extensions: recent litigations suggest possible supplementary protections via data exclusivity.
- Geographic expansion: entry into new markets, especially in Asia, could influence global pricing dynamics.
Price Projection Outlook (2023–2027)
| Year |
Estimated WAC per Vial (USD) |
Expected Market Share of Biosimilars |
Price Trend |
Notes |
| 2023 |
4,200 |
25% |
Stable, slight decline |
Biosimilar competition softens prices. |
| 2024 |
4,000 |
40% |
Decline of 8-10% |
Increased biosimilar market share. |
| 2025 |
3,800 |
60% |
Decline of 12-15% |
Biosimilars displacing originator in more regions. |
| 2026 |
3,500 |
80% |
Stabilization |
Main markets saturated with biosimilars. |
| 2027 |
3,300 |
90% |
Further reduction |
Cost pressures increase, access expands. |
Global Price Trends
- The overall global price for a standard course could decrease by approximately 30% by 2027, with notable variability based on regional healthcare policies,
- North America may see a slightly lesser decline (around 25%) due to brand loyalty and insurance negotiations.
- Emerging markets might experience steeper reductions, coupled with increased access.
Risks and Opportunities
Risks
- Regulatory delays for biosimilar approvals could delay market share gains.
- Patent litigation might limit biosimilar entry timelines.
- Physician and patient acceptance of biosimilars remains variable, influencing price elasticity.
Opportunities
- Market expansion in Asia and Latin America presents growth potential.
- Cost reductions enable broader treatment access, supporting volume growth.
- Strategic partnerships for biosimilar development and distribution could enhance margins.
Key Takeaways
- NDC 13668-0462 refers to Herceptin, a mature biologic with growing biosimilar competition.
- Sales are sustained by expanding indications, with sales plateauing post-2018 due to biosimilar entry and price competition.
- In the U.S., current list prices hover around USD 4,600 per vial, with biosimilar prices roughly USD 2,500–USD 3,200.
- The global market price is expected to decline approximately 30% through 2027, driven by biosimilar adoption.
- Patent and regulatory environments will significantly influence future price trajectories.
FAQs
1. What are the primary indications for Herceptin (NDC 13668-0462)?
Herceptin is approved for HER2-positive early and metastatic breast cancer, including adjuvant and neoadjuvant settings, and for HER2-positive gastric and gastroesophageal junction cancers.
2. How does biosimilar entry impact Herceptin’s pricing?
Biosimilar introduction leads to price reductions of 25-35% on list prices, increasing market competition and lowering treatment costs.
3. Are biosimilars covered by insurance in the U.S.?
Many U.S. insurers cover biosimilars, often favoring them due to lower costs; however, coverage policies vary and may influence adoption rates.
4. What factors could delay biosimilar market penetration?
Regulatory hurdles, patent litigation, and physician or patient hesitancy may slow biosimilar adoption, delaying price reductions.
5. What market expansion opportunities exist for Herceptin?
Markets in Asia, Latin America, and Africa present growth opportunities owing to increasing cancer incidence and improving healthcare infrastructure.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2019). Approval of biosimilars for Herceptin.
[3] Evaluate Pharma. (2022). World Preview 2022: Outlook to 2027.
[4] IMS Health. (2021). Biologics Price Trends.
