Nichi-Iko Pharmaceutical Co., Ltd. has recently announced 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.
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.
Source:
https://www.nichiiko.co.jp/company/press/
https://www.nichiiko.co.jp/company/press/detail/5325/1468/4541_20220120_01.pdf