In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals . However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) .
If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials , has been developed by researchers National and Kapodistrian University of Athens.
The first approved bevacizumab biosimilar, ABP 215 (Mvasi), can be prepared in- bag, over a month prior to being used to treat patients via intravenous (IV) infusion, shows a study published in GaBI Journal . The study reveals that ABP 215 retains physicochemical stability after dilution and storage, which can ease the process of drug administration in clinical settings.
Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).