Biosimilar medicines and safety: New challenges for pharmacovigilance

Abstract

Abstract. Regulatory experience of approving and monitoring safety of biosimilar medicines varies across the World. Recentlythe European Union has taken lead in establishing a transparent regulatory process for approving biosimilars. The EU to datehas approved a number of biosimilars, such as several formulations of somatotropin, epoetin and most recently, filgrastim. Theprevailing view among regulators is that as proteins are much more complex than small molecule medicines, it may not bepossible to demonstrate the identical nature of two biological products originating from different manufacturing sources solelybased on quality information. This leads to the thinking that follow-on biological products manufactured after expiry of patentand other exclusivity rights by “generic” manufacturers can not be approved using the same simplified regulatory proceduresas applied for small molecule based generic drugs. Generating additional nonclinical and clinical data to demonstrate that thesemedicines have an equivalent, or similar, safety and efficacy profile to the originator product is needed. However, several partieshave raised concerns that these regulatory measures may not be enough to ensure the safety and efficacy of these products. Inthis article a short review of regulatory experience, main principles and issues concerning quality, safety and efficacy (as ofteninseparable) of these products is given.Keywords: Biosimilar, pharmacovigilance, drug safety, drug regulation