Last updated: March 3, 2026
What is NDC 65162-0680?
NDC 65162-0680 refers to a biosimilar product, specifically a biosimilar version of a reference biologic. It is crucial to identify the active ingredient, therapeutic area, and approved indications to determine the market landscape accurately.
Based on current data, NDC 65162-0680 corresponds to Bevacizumab-bvzr (Zirabev), a biosimilar of Avastin (bevacizumab), used in oncology for treating various cancers including colorectal, lung, renal cell carcinoma, and glioblastoma.
What is the current market size for bevacizumab biosimilars?
The global biologics market was valued at approximately USD 307 billion in 2022, with oncology biosimilars accounting for a significant share, projected to grow at a CAGR of 9.3% from 2023 to 2030 (Grand View Research, 2023).
The oncology biosimilar segment specifically reached USD 12 billion in 2022, driven by expiring patents of originator biologics like Avastin, Herceptin, and Humira.
Market penetration of bevacizumab biosimilars:
| Year |
Estimated Global Sales (USD billion) |
Market Share of Bevacizumab Biosimilars |
| 2022 |
12 |
15% |
| 2025 |
20 |
35% |
| 2030 |
30 |
50% |
The increasing adoption stems from cost savings, with biosimilars priced approximately 20%–30% lower than originators.
Who are the key competitors?
Major biosimilar developers include:
- Celltrion Healthcare: Produces Zirabev (NDC 65162-0680), approved by the FDA in 2020.
- Sandoz (Novartis): Kisqali and other biosimilars.
- Amgen: Developing biosimilars with similar indications.
- Medytox: Engaged in biosimilar oncology agents.
Other competitors focusing on bevacizumab biosimilars:
- Samsung Biologics
- Biocon
- HosungBio
What are the pricing trends?
In the United States, biosimilar prices for bevacizumab generally range from USD 1,200 to USD 2,000 per vial, compared to the USD 4,700–USD 5,000 per vial for the originator (Avastin).
Price decrease over time:
| Year |
Average Biosimilar Price per vial (USD) |
% Reduction from 2021 |
| 2021 |
USD 3,900 |
0% |
| 2022 |
USD 2,000 |
48% |
| 2023 |
USD 1,500 |
62% |
The price projections suggest continued downward shifts as manufacturing efficiencies improve and market competition intensifies.
Regulatory landscape and approval trends
FDA approved Zirabev in 2020 with indications matching Avastin. European Medicines Agency (EMA) approved it in 2019.
Upcoming biosimilar entries are subject to regulatory pathways:
- FDA: 351(k) biosimilar pathway.
- EMA: Similar biosimilar approval procedures.
Regulatory approvals are driven by the expiration of Avastin patents in major markets:
| Market |
Patent Expiry |
Biosimilar Launch Date |
Number of Approved Biosimilars |
| US |
2018 |
2020 |
3 (including Zirabev) |
| EU |
2018 |
2019 |
4 |
Market growth drivers and barriers
Drivers:
- Expiring patents of Avastin (2018)
- Cost reduction for healthcare providers
- Growing cancer prevalence rates
- Encouragement of biosimilar prescribing policies
Barriers:
- Physician hesitancy due to perceived efficacy concerns
- Payer negotiations affecting reimbursement
- Limited market penetration in certain regions
Price projections (2023–2030)
Based on current trends, biosimilar prices are expected to decline by an additional 10%–15% annually until 2030, reaching approximately USD 1,000 per vial in the US and European markets.
Market penetration forecast:
| Year |
Estimated % of Avastin market share |
Total US biosimilar sales (USD billion) |
| 2023 |
25% |
3.75 |
| 2025 |
40% |
8.0 |
| 2030 |
50% |
15.0 |
Key Takeaways
- NDC 65162-0680 (Zirabev) is a leading bevacizumab biosimilar, with rapid adoption due to cost advantages.
- The global biosimilar oncology market is expanding at a robust CAGR of approximately 9.3%, reaching USD 30 billion by 2030.
- Pricing is expected to stabilize around USD 1,000 to USD 1,500 per vial by the late 2020s.
- Competition from multiple biosimilar manufacturers ensures continuous price decline and increased market share.
- Regulatory approvals remain consistent, supporting market expansion, especially in North America and Europe.
FAQs
1. How does the pricing of Zirabev compare to the originator Avastin?
Zirabev costs approximately 60%–70% less per vial, translating to significant savings in treatment costs.
2. What influence will future patent expirations have?
Additional patent expirations in emerging markets will likely increase biosimilar availability, further reducing prices and expanding access.
3. Are biosimilar therapies equivalent in efficacy?
Regulatory agencies require biosimilars to demonstrate similar efficacy, safety, and immunogenicity profiles to their reference biologics.
4. What are the challenges in biosimilar market penetration?
Physician skepticism, payer restrictions, and limited awareness hinder biosimilar adoption in some regions.
5. How do regulatory environments affect biosimilar market growth?
Streamlined approval processes and favorable policies accelerate biosimilar entry, boosting competition and pricing pressure.
References:
[1] Grand View Research. (2023). Biosimilars Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2020). FDA approves Zirabev, a biosimilar of Avastin.
[3] European Medicines Agency. (2019). EMA approves Zirabev, a biosimilar of Avastin.
