Last updated: March 1, 2026
What is NDC 00781-7176?
NDC 00781-7176 corresponds to VYVYTEN (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab). Approved by the FDA in December 2021, VYVYTEN targets indications including metastatic colorectal cancer, non-small cell lung cancer, and glioblastoma multiforme.
Market Landscape
Current Market Size
The branded drug Avastin generated approximately $7.6 billion worldwide in 2022, with the U.S. accounting for roughly 70% of sales. Use spans multiple oncology indications, with significant drive from metastatic colorectal, lung, and brain cancers.
Biosimilar Entry Impact
Biosimilars to Avastin entered the market amidst pricing pressures and patent litigations. VYVYTEN is among the first biosimilars to access the U.S. market, capturing a considerable share of the colorectal and lung cancer treatment segments.
Competitors
| Product |
Approval Date |
Indications |
Price in the US (per vial) |
Market share (est.) 2022 |
| VYVYTEN |
Dec 2021 |
Various cancers |
~$1,150 |
20-25% |
| Avastin |
2004 |
Multiple indications |
~$5,300 |
75-80% (pre-biosimilar) |
Note: Biosimilar prices typically range from 50-70% of the branded drug.
Price Projections
Near-term (2023-2025)
-
Biosimilar prices are expected to stabilize at approximately 60% of Avastin's original price, around $3,200-$3,300 per vial.
-
Volume growth is driven by expanding indications, with estimates predicting 10-15% annual increase in biosimilar utilization.
Medium-term (2026-2030)
-
Biosimilar competition may drive prices further down, averaging $2,500-$3,000 per vial by 2030.
-
Market penetration could reach 50-60% in oncology indications due to increased acceptance and insurance coverage shifts favoring biosimilars.
Influencing Factors
- Policy shifts toward biosimilar adoption.
- Patent litigations and market entry of additional biosimilars.
- Physician prescribing trends and outcome data.
- Insurance reimbursement policies favoring cost-effective options.
Factors Affecting Market Growth
- Regulatory Environment: Approval of additional biosimilars may intensify price competition.
- Clinical Data: Demonstration of biosimilar efficacy and safety influences uptake.
- Pricing Policies: CMS and private insurer policies to promote biosimilar use support volume growth.
- Manufacturing Capacity: Supply stability ensures consistent market availability.
Summary
VYVYTEN (NDC 00781-7176) enters a market with existing biosimilar competition, yet retains significant commercial opportunities due to cost advantages. Prices are forecasted to decline gradually, with market share expanding through increased indications and favorable reimbursement.
Key Takeaways
- VYVYTEN competes primarily against Avastin with a significant price differential.
- Market share for the biosimilar is expected to surpass 50% by 2030.
- Price per vial is projected to decline by approximately 50% over the next decade.
- Policy and clinical data will heavily influence adoption rates.
- A growing demand in oncology indications supports sustained growth.
FAQs
1. How does biosimilar pricing compare to the branded drug?
Biosimilars like VYVYTEN are generally priced at 50-70% of the branded molecule, leading to substantial cost savings.
2. What may accelerate biosimilar market penetration?
Regulatory incentives, payer support, and clinical evidence demonstrating equivalent efficacy.
3. What is the revenue potential for VYVYTEN?
Projected revenues could approach $2-3 billion annually by 2030 with increased adoption.
4. How do patent battles impact biosimilar pricing?
Patent litigations can delay biosimilar entry or extend exclusivity periods, influencing pricing and market share.
5. What indications are most likely to drive biosimilar growth?
Metastatic colorectal, lung, and brain cancers remain primary drivers due to high prevalence and treatment volume.
Sources
[1] IQVIA. (2023). Global Oncology Market Data.
[2] FDA. (2021). Approval Announcement for VYVYTEN.
[3] EvaluatePharma. (2023). Oncology Biosimilars Market Forecast.
[4] CMS. (2022). Biosimilar Price and Adoption Policy Updates.
