Pfizer’s Biosimilar ZIRABEV (Bevacizumab-bvzr) Receives FDA Approval for Five Oncology Indications

June 29, 2019 News /BioValleyBIOON/ -- Pharmaceutical GiantPfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has approved Zirabev (bevacizumab-bvzr, bevacizumab), which is the biosimilar of Roche’s brand-name drug Avastin (generic name: bevacizumab)Biosimilars, indicated for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent, or metastatic cervical cancer.

Zirabev is the 21st biosimilar approved by the FDA and the second bevacizumab biosimilar. In September 2017, Amgen and Allergan’s Mvasi (bevacizumab-awwb) receivedFDAApproved, becoming the first bevacizumab approved for the U.S. marketBiosimilars。

Pfizer has a robust biosimilar pipeline, with Zirabev following the approval of Trazimera (trastuzumab-qyyp) in March this year.FDAThe Second ApprovedTumorMonoclonal Antibody ClassBiosimilars. In the European Union, Zirabev was approved in February this year for the treatment of: metastatic colorectal cancer, metastaticBreast Cancer, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell carcinoma (RCC), persistent, recurrent, or metastatic cervical cancer.

PfizerTumorAndy Schmeltz, President of Pfizer Global, stated: “Products such as ZirabevBiosimilarsIt can help improve patients’ access to effective therapies, foster market competition, and ultimately may reduce costs, thereby helping to meet the diverse needs of cancer patients. We are honored to add Zirabev to our growing oncology portfolio, for individuals living with variousTumorservices for American patients of various types.”

Avastin is a blockbuster biologic agent from Roche. According to the company’s 2018 annual performance report, Avastin was the second best-selling drug, following Herceptin (CHF 6.992 billion), with global sales of CHF 6.849 billion in 2018, representing a 3% increase compared to 2017. Sales in the U.S. market amounted to CHF 2.904 billion, a 1% increase; sales in the European market totaled CHF 1.820 billion, a 1% decrease; sales in the Japanese market reached CHF 847 million, a 3% increase; and sales in other international markets amounted to USD 1.278 billion, a 12% increase.

The approval of Zirabev is based on a comprehensive data package. These data confirm the biosimilarity of Zirabev to the reference product Avastin, including data from the Phase III REFLECTIONS B7391003 comparative clinical study, which demonstrated the clinical equivalence of Zirabev and Avastin in the treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC), with no clinically meaningful differences observed. As part of the overall REFLECTIONS clinical development program, Zirabev has been studied in approximately 400 patients. (Bioon.com)

Original Source:Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)