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 (mCRC).... Read More
HERITAGE
For over four decades, Amgen has been at the forefront of biologic innovation with the discovery, development, and production of novel medicines and support services for patients with cancer.
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.
COMMITMENT
SUPPORT
With both Amgen Assist 360™ and Amgen FIRST STEP™ programs available for our biosimilars, you’ll see the same support you’ve come to expect from Amgen.
Serious adverse reactions (Warnings and Precautions)
Pregnancy warning
Most common adverse reactions
Indication-specific adverse reactions
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.
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 (mCRC).
MVASI®, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC 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 (NSCLC).
MVASI® is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
MVASI®, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
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 (CC).
MVASI®, in combination with carboplatin and paclitaxel, followed by MVASI® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection (OC).
MVASI®, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens (OC).
MVASI®, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by MVASI® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (OC).
MVASI® Important Safety Information
Serious adverse reactions (Warnings and Precautions)
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 [Drug Shortages]; 2021.
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 [Drug Shortages]; 2021.