FDA approves Zirabev , bevacizumab biosimilar

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin. The biosimilar will be sold as Zirabev. The drug has been approved for the treatment of metastatic colorectal cancer, recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.

Among the data Pfizer generated in support of the biosimilar’s approval were those from the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of the biosimilar versus the reference bevacizumab. The trial enrolled 719 patients with advanced nonsquamous NSCLC. The study demonstrated equivalence in the primary end point of objective response rate of the biosimilar versus the reference when taken in combination with carboplatin/paclitaxel for first-line treatment of NSCLC. Additionally, a phase 1 pharmacokinetic (PD) study1 of the biosimilar was conducted in 102 healthy males volunteers. In the double-blind study, the volunteers received single 5 mg per kg intravenous doses of either the biosimilar, the EU-licensed reference product, or the US-licensed reference product. PK similarity was achieved if 90% CIs for the test-to-reference ratios of the maximum serum concentration, area under the serum concentration–time curve from zero to infinity, and from zero to time of last quantifiable concentration fell within the 80% to 125% bioequivalence acceptance window. The 90% CIs for all 3 parameters fell within the prespecified margin.

Pfizer’s biosimilar is also approved in the European Union; Zirabev earned the European Commission’s approval in February 2019 after having received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2018.