Last updated: March 13, 2026
What is NDC 68180-0964?
NDC 68180-0964 is the identifier for Bevacizumab-avastin (biosimilar) marketed by Mvasi, developed by Pfizer. It is a biosimilar to the reference product Avastin (bevacizumab). Approved by the FDA in 2021, it is indicated for various cancers, including metastatic colorectal cancer, non-small cell lung cancer, and glioblastoma.
Market Size and Current Adoption
Pre-Existing Market for Avastin
- Global sales of Avastin exceeded $6.8 billion in 2022, with a strong presence in oncology.
- The U.S. accounted for nearly 50% of revenues, with approximate sales close to $3.4 billion.
- Major indications include metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and others.
Biosimilar Entry
- Mvasi was the first FDA-approved biosimilar for Avastin, approved in June 2017; however, its commercial impact took several years to materialize.
- The biosimilar market penetration has increased with subsequent approvals and drop-in price strategies.
Current Market Penetration
- As of 2022, biosimilar Avastin products account for roughly 20% of Avastin's total market share in the U.S., equating to approximately $600 million annual sales among biosimilars.
- Mvasi holds an estimated 12-15% market share within the biosimilar segment, driven by provider familiarity and formulary access.
Market Drivers
- Expiration of primary patents in 2022-2024 in various regions enhances biosimilar adoption.
- Cost reduction initiatives by healthcare providers and payers favor biosimilar use.
- Increased clinical adoption in oncology protocols and expanding indications support growth.
Competitive Landscape
Biosimilars for Bevacizumab
| Biosimilar |
Manufacturer |
Approval Date |
Market Share (2022) |
Price Discount vs. Reference |
Indications |
| Mvasi |
Pfizer |
June 2017 |
12-15% in biosimilars |
~15-20% lower than Avastin |
Multiple oncology indications |
| Zirabev |
Zydus |
July 2019 |
Limited, mainly India |
25% lower in Indian market |
Oncology |
Price Trends
- The wholesale acquisition cost (WAC) for Avastin in the U.S. was approximately $11,000 per 400 mg vial in 2022.
- Biosimilar prices average 15-20% lower, with some discounts reaching 25% depending on the payer agreements and volume.
Price Projections (2023-2027)
Assumptions
- Incremental biosimilar market share increase at 5-10% annually, reaching 50-60% in five years.
- Continued cost-driven adoption, with pricing discounts remaining steady at 15-20%.
- The FDA approves additional biosimilars, increasing competition and driving prices downward.
Projected Wholesale Price Trends
| Year |
Estimated Biosimilar Price Discount |
Estimated Average Price per 400 mg Vial |
Projected Market Share |
Expected Revenue (U.S.) |
Notes |
| 2023 |
15% |
~$9,350 |
20% |
~$440 million |
Year of increased biosimilar uptake |
| 2024 |
20% |
~$8,800 |
30% |
~$660 million |
Additional biosimilars enter market |
| 2025 |
20% |
~$8,800 |
45% |
~$1 billion |
Market stabilizes with higher adoption |
| 2026 |
20% |
~$8,800 |
55% |
~$1.2 billion |
Increased payer incentivization |
| 2027 |
20% |
~$8,800 |
60% |
~$1.3 billion |
Full biosimilar integration with reduced prices |
(All prices are estimates based on current trends)
Regulatory and Policy Impact
- International markets, especially in Europe, have a more aggressive biosimilar adoption curve due to established policies to cut healthcare costs.
- The U.S. has introduced policies such as "biosimilar automatic substitution" laws in some states, expected to accelerate uptake.
- Patent litigations post-expiration could influence the entry timing of additional biosimilars, potentially affecting pricing and market share dynamics.
Key Risks and Opportunities
- Risks: Slow uptake due to provider hesitation, payer restrictions, and patent litigations delaying product launch.
- Opportunities: Provider education, expanded indications, and volume-based discounts accelerating market penetration.
Final Summary
NDC 68180-0964, as Pfizer’s Mvasi biosimilar to Avastin, currently captures around 12-15% of the biosimilar market with annual revenues estimated at $100-150 million. Market share is poised to grow to approximately 50-60% within five years, with prices declining by roughly 15-20%. The overall biosimilar segment for bevacizumab may reach $1.3 billion in the U.S. by 2027, driven by ongoing patent expirations, cost-containment efforts, and expanded oncology indications.
Key Takeaways
- Biosimilar market share for bevacizumab in the U.S. is projected to more than double by 2027.
- Price reductions of 15-20% relative to reference Avastin are typical for biosimilars.
- The total biosimilar market potential in the U.S. could surpass $1 billion in revenues for bevacizumab biosimilars by 2027.
- Market trends driven by policy, payer incentives, and clinical adoption influence growth.
- Competition among biosimilars is expected to lower prices further, expanding access.
FAQs
Q1: How does the biosimilar approval process affect market entry timing?
A1: The FDA's biosimilar approval process, requiring evidence of similarity and safety, can delay market entry compared to small-molecule generics but ensures confidence in efficacy.
Q2: Will biosimilar prices continue to decline?
A2: Yes, increased competition, payer negotiations, and policy incentives are likely to push biosimilar prices downward over the next few years.
Q3: What does market growth depend on most?
A3: Growth primarily depends on regulatory approvals, hospital and provider acceptance, payer policies, and expansion of approved indications.
Q4: How does biosimilar market share impact revenue for manufacturers?
A4: As biosimilar market share increases, revenue shifts from the reference product to biosimilar manufacturers, assuming volume increases and price discounts offset.
Q5: Are there barriers preventing biosimilar adoption?
A5: Yes, including provider familiarity, patent litigations, payer restrictions, and manufacturing or supply chain issues.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2021). Biologics Price Competition and Innovation Act.
[3] EvaluatePharma. (2022). Oncology Market Forecasts.
[4] Centers for Medicare & Medicaid Services. (2022). Drug Price Policies.
