FDA Approves Zirabev, Second Avastin Biosimilar

June 28, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved Zirabev (bevacizumab-bvzr; Pfizer Inc.), a biosimilar to Avastin (bevacizumab; Genentech, Inc.). Both products are oncology monoclonal antibodies that inhibit the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor protein.

Zirabev is the second Avastin biosimilar. Mvasi (bevacizumab-awwb; Amgen, Inc.) was approved in September 2017; it was the first biosimilar approved in the United States for the treatment of cancer. Neither Avastin nor Mvasi is approved as an interchangeable product.

Zirabev is administered by intravenous infusion. It is approved for the treatment of the following types of cancers in adult patients:

  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first-line or second-line treatment. Zirabev is not indicated for adjuvant treatment of colon cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan–based chemotherapy or fluoropyrmidine-oxaliplatin–based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Zirabev is not indicated for adjuvant treatment of colon cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel, for first line treatment of unresectable, locally advanced, recurrent, or metastatic disease.
  • Recurrent glioblastoma.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

The Boxed Warning for gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding (hemorrhage) was removed from the Avastin prescribing information in June 2019 and does not appear in the Zirabev prescribing information.