(en) Biosimilars are biological drugs which are similar to the authorized biologics (“reference product”) but not identical (1). The European legislation has offered since 2006 a legal framework for biosimilars. The concept and methodology of the comparative investigations are further treated in the guidelines of the European Medicines Agency (EMA) [...]
Franchimont, D., Ferrante, M., Louis, E., De Vos, M., Dewit, O., Van Hootegem, P., Moreels, T., Liefferinckx, C., Bossuyt, P., Baert, F., Rahier, J.-F., & Vermeire, S. (2018). Belgian IBD research group (BIRD) position statement 2017 on the use of biosimilars in inflammatory bowel diseases (IBD). Acta Gastro-Enterologica Belgica, 81(1), 49-53. https://hdl.handle.net/2078.5/173521 (Original work published 2018)