FDA Accepts Application for Bevacizumab Biosimilar

November 19, 2019 – The FDA has accepted a biologics license application (BLA) for the proposed bevacizumab biosimilar SB8, according to Samsung Bioepis, the developer of the agent. Phase III findings for SB8 were presented at the 2019 ESMO Congress, in which the biosimilar demonstrated similar efficacy in terms of best overall response rate (ORR) risk ratio compared with reference bevacizumab in patients with metastatic or recurrent nonsquamous … (leggi tutto)