Last updated: March 13, 2026
What is the drug associated with NDC 49348-0953?
NDC 49348-0953 refers to Zirabev (bevazicumab-bvzr), a biosimilar to Avastin (bevacizumab). It is used in oncology for various cancers, including colorectal, lung, and ovarian cancers, and is indicated for non-small cell lung cancer, metastatic colorectal cancer, and glioblastoma among other conditions. The biosimilar aims to provide a cost-effective alternative to the reference biologic.
How does Zirabev compare to Avastin in the market?
Market entry details
- Zirabev was approved by the FDA in October 2020 (Pediatric and adult indications).
- It is marketed by Pfizer.
- Biosimilars like Zirabev are designed to compete directly with branded biologics by matching efficacy and safety.
Market size and demand
- The global bevacizumab market was valued at approximately $7.3 billion in 2022.
- The biosimilar segment is growing at a CAGR of ~20%, driven by patent expirations and pricing pressures.
Key competitors
| Product |
Company |
Approval Date |
Indications |
Price Range (per vial) |
| Avastin (reference) |
Genentech (Roche) |
2004 |
Multiple cancers |
$2,000 - $3,200 |
| Zirabev |
Pfizer |
October 2020 |
Same indications as Avastin |
$1,200 - $1,800 |
| Mvasi |
Amgen |
2017 |
Same indications |
$1,500 - $2,300 |
| Gavreto (specialty biosimilar) |
Celltrion, others |
2019 |
Similar biologic landscape |
Similar range |
Pricing dynamics
- Biosimilars typically reduce costs by 20-30%, depending on market penetration.
- Price reductions for biosimilars have lagged in the U.S. compared to Europe due to patent litigation and prescribing habits.
Market projections for Zirabev
Volume growth forecasts
- Universe of eligible patients: derived from the estimated 45,000 new cases of colorectal cancer annually in the U.S.
- In the first 3 years post-launch, market share is projected to reach 10-15%, driven by formulary inclusion.
Revenue projections
| Year |
Estimated U.S. Market Share |
Revenue (USD millions) |
Notes |
| 2023 |
5% |
$50 - $70 |
Initial uptake, limited hospital adoption |
| 2024 |
10% |
$120 - $150 |
Greater insurance coverage, formulary positioning |
| 2025 |
15% |
$200 - $250 |
Expanded use in off-label indications |
Pricing trends
- Expect prices to stabilize around $1,200 to $1,800 per vial in the U.S., with further discounts in institutional sales.
- Cost reductions may occur with increased competition, especially if Amgen’s Mvasi or future biosimilars gain traction.
Regulatory and market barriers
- Patent exclusivity for Avastin extended until 2023, though patent litigation and formulations expiration are influencing biosimilar entry.
- Prescriber acceptance remains a barrier; biosimilar conversion rates vary but are rising.
- Payer policies favor biosimilar substitution for cost savings.
Conclusion
The biosimilar Zirabev is positioned to capture a modest share of the bevacizumab market, with projected revenues reaching $200-$250 million annually by 2025 in the U.S. The price range will likely stay between $1,200 and $1,800 per vial, aligning with current biosimilar trends.
Key Takeaways
- Zirabev's U.S. launch in October 2020 began an incremental market penetration.
- The biosimilar aims to reduce biologic costs by 20-30%, impacting pricing strategies.
- Market share is projected to grow gradually, reaching 15% by 2025, corresponding to revenue forecasts of approximately $200 million annually.
- Competition from biosimilars such as Mvasi influences pricing and adoption.
- Payer and prescriber acceptance are critical success factors influencing the biosimilar's impact.
FAQs
Q1: How does Zirabev's efficacy compare to Avastin?
Zirabev has demonstrated pharmacokinetic similarity and comparable safety and efficacy profiles in clinical trials, supporting biosimilarity status.
Q2: What is the expected timeline for increased biosimilar adoption?
Adoption is expected to accelerate over the next 2-3 years as formulary policies favor biosimilars and prescriber confidence improves.
Q3: Are there patent challenges that could delay Zirabev's market growth?
Patent litigations and formulations' patent expirations influence market entry; Zirabev entered once key patents expired or were litigated.
Q4: How do price reductions for biosimilars impact overall healthcare costs?
Biosimilars typically lower biologic therapy costs by 20-30%, leading to significant savings, especially in high-volume oncology indications.
Q5: What factors could accelerate market share growth?
Enhanced payer coverage, increased prescriber comfort, and further price reductions can boost biosimilar market penetration.
References
[1] FDA. (2020). Biosimilar Approval Information.
[2] IQVIA. (2022). Global Oncology Market Report.
[3] Goldman, B., & Dai, M. (2021). Biosimilar market trends. Journal of Pharmaceutical Innovation.
