FDA Approval Sought for Rituximab Biosimilar

December 20, 2019 – A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798, according to the developers, Amgen and Allergan. The application is based on analytical, pharmacokinetic, and clinical data, and also pharmacology and toxicology data from 2 clinical trials, results of which showed that there were no clinically meaningful differences between ABP 798 and reference rituximab. “The US filing for ABP 798 … (leggi tutto)