On February 23, 2022 Nichi-Iko Pharmaceutical Co., Ltd. has recently reported that it received approval for a biosimilar of bevacizumab BS intravenous infusion 100 mg/400 mg, whose marketing authorization application was filed based on the clinical pharmacokinetic (PK) study data conducted in Japan in addition to the global Phase 3 study data conducted by mAbxience (Press release, mAbxience, FEB 23, 2022, View Source [SID1234608885]).
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Bevacizumab BS is highly similar to the reference medicinal product and data has shown a comparable quality, safety and efficacy to Avastin. Bevacizumab BS is indicated for the treatment of advanced or recurrent colorectal cancer that is not curatively resectable and advanced or recurrent non-small cell lung cancer that is not resectable except for squamous cell carcinoma.