MVASI™ is a vascular endothelial growth factor inhibitor indicated for the treatment of: MVASI™, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer... Read More
HERITAGE
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EXPERTISE
The FDA requires a totality of evidence* to establish similarity.2
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*Totality of evidence establishes structural and functional equivalence, and includes nonclinical evaluation, human pharmacokinetic (PK) and pharmacodynamic (PD) data, clinical immunogenicity data, and comparative clinical study data.2
Da = Dalton, 1 atomic mass unit; mAb = monoclonal antibody.
For more educational information on biosimilars, visit BioEngage.
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Pregnancy warning
Most common adverse events
Indication-specific adverse events
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.
Please see full Prescribing Information for additional Important Safety Information.
MVASI™ Indications
MVASI™ is a vascular endothelial growth factor inhibitor indicated for the treatment of:
MVASI™, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer.
MVASI™, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: MVASI™ is not indicated for adjuvant treatment of colon cancer.
MVASI™, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.
MVASI™ is indicated for the treatment of recurrent glioblastoma in adults.
MVASI™, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma.
MVASI™, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Avastin® (bevacizumab) is a registered trademark of Genentech USA, Inc.
MVASI™ Important Safety Information
References: 1. Data on file, Amgen; 2019 [Biologics Quality Checks]. 2. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed March 2, 2020. 3. US Food and Drug Administration. ODAC briefing document: ABP 215, a proposed biosimilar to US-Avastin. BLA 761028. July 13, 2017. 4. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 5. Nickish K, Bode-Greuel KM. NPV modelling for the selection of value-creating biosimilar development candidates. J Commer Biotechnol. 2013;19:24-32. 6. Aspirin Prescribing Information, Bayer. 7. Humalog® (insulin lispro injection) Prescribing Information [revised 2017], Eli Lilly. 8. Humatrope® [somatropin (rDNA ORIGIN)] Prescribing Information [revised 2016], Eli Lilly. 9. Taltz® (ixekizumab) Prescribing Information [revised 2017], Eli Lilly. 10. Data on file, Amgen; 2018. 11. Data on file, Amgen; 2019.
References: 1. Data on file, Amgen; 2019 [Biologics Quality Checks]. 2. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed March 2, 2020. 3. US Food and Drug Administration. ODAC briefing document: ABP 215, a proposed biosimilar to US-Avastin. BLA 761028. July 13, 2017. 4. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 5. Aspirin Prescribing Information, Bayer. 6. Humalog® (insulin lispro injection) Prescribing Information [revised 2017], Eli Lilly. 7. Humatrope® [somatropin (rDNA ORIGIN)] Prescribing Information [revised 2016], Eli Lilly. 8. Taltz® (ixekizumab) Prescribing Information [revised 2017], Eli Lilly. 9. Nickish K, Bode-Greuel KM. NPV modelling for the selection of value-creating biosimilar development candidates. J Commer Biotechnol. 2013;19:24-32. 10. Data on file, Amgen; 2018. 11. Data on file, Amgen; 2019.