Posted from: Friday, August 09, 2019 - 01:57 PM - Present

Zirabev Approved as a Biosimilar for Avastin

June 28, 2019 – The U.S. FDA has approved Zirabev™ (bevacizumab-bvzr), manufactured by Pfizer, as a biosimilar for Genentech’s Avastin® (bevacizumab). It is indicated to treat metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.

In a clinical comparative study, Zirabev was found to be clinically equivalent to Avastin, with no clinically meaningful differences between the two products in patients who had NSCLC. Recommended dosing is based on the indication and on the patient’s weight.

Zirabev is the second biosimilar for Avastin to receive FDA approval. Amgen’s Mvasi™ (bevacizumab-awwb) was approved in 2017, but has not been launched. Pfizer has not announced launch or pricing plans for Zirabev. Legal disputes may delay the launch of Avastin biosimilars until 2020.

Last Updated Saturday, August 17, 2019 - 04:09 AM.