Biosimilar medicines and safety: New challenges for pharmacovigilance

Issue title: Biologicals – Pharmaceuticals, Blood Products and Vaccines

Article type: Research Article

Authors: Rägo, Lembit

Affiliations: WHO, Geneva, Switzerland

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

Keywords: Biosimilar, pharmacovigilance, drug safety, drug regulation

DOI: 10.3233/JRS-2009-0456

Journal: International Journal of Risk and Safety in Medicine, vol. 21, no. 1-2, pp. 5-11, 2009