- Trial Phase
- Approved
- Time to Market
- Already approved and marketed since September 2017.
- Why 4/10
- MVASI is an approved, marketed biosimilar with no pending regulatory decision, pivotal readout, or binary catalyst scheduled in the next 12 months. It represents roughly 2% of Amgen's total revenue, making it a small part of a large, diversified pipeline. Per the impact score rubric, an approved drug with no upcoming binary catalyst scores 3-5, and MVASI's modest revenue share places it at 4.
MVASI has no upcoming PDUFA, pivotal readout, or binary catalyst. The next scheduled event is Amgen's Q4 2026 earnings release (likely early February 2027), where MVASI's ongoing sales erosion from biosimilar competition and pricing pressure will be one data point among many in a diversified portfolio. For a non-medical investor, MVASI is a slow-moving, commoditized asset within a large-cap biotech; watch the broader bevacizumab biosimilar market ASP trends and Amgen's overall biosimilar franchise performance rather than this single drug.
Price Chart
Executive Summary
MVASI (bevacizumab-awwb) is Amgen's FDA-approved biosimilar to Genentech/Roche's Avastin (bevacizumab), a VEGF-inhibitor monoclonal antibody used across multiple cancer types. Approved in September 2017 as the first anti-cancer biosimilar in the U.S., MVASI is a mature, marketed product with no pending regulatory catalysts. It holds roughly 51% of U.S. bevacizumab biosimilar volume but faces intensifying competition from at least five other FDA-approved biosimilars (Zirabev, Alymsys, Vegzelma, Avzivi, Jobevne) and ongoing pricing erosion. MVASI generated approximately $771 million in 2025 sales (about 2% of Amgen's $36.8 billion total revenue), but Q3 2026 sales fell 21% year-over-year to $168 million, driven by lower net selling price and volume. For Amgen, a $479 stock with a broad portfolio of blockbuster drugs, MVASI is a modest contributor with a slow erosion trajectory rather than a value-driving catalyst.
How It Works
MVASI is a biosimilar (a highly similar, lower-cost copy) of the cancer drug Avastin. It works by blocking a protein called VEGF that tumors use to grow new blood vessels. By cutting off the blood supply, it starves the tumor and slows its growth. It is given as an intravenous infusion, usually alongside chemotherapy, for several types of cancer.
Trial Status
FDA approved September 14, 2017 as the first anti-cancer biosimilar in the U.S. Marketed for all eligible indications of the reference product Avastin (bevacizumab), including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, and others. No active clinical trials for MVASI as a biosimilar; it is a fully approved commercial product.
The Two-Sided Case
Upcoming Catalysts
- Amgen Q4 2026 earnings (early February 2027) - MVASI quarterly sales and full-year 2026 results.
- Biosimilar market share reports from Samsung Bioepis and other sources tracking bevacizumab biosimilar penetration and ASP trends.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report