Pharmacovigilance of biosimilars from a regulatory point of view: Is there a need for a specific approach?

Issue title: Biologicals – Pharmaceuticals, Blood Products and Vaccines

Article type: Research Article

Authors: Giezen, Thijs J.^{; ;} | Straus, Sabine M.J.M. | Mantel-Teeuwisse, Aukje K.^;

Affiliations: Medicines Evaluation Board, The Hague, The Netherlands | Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, The Netherlands

Note: [] Address for correspondence: T.J. Giezen, PharmD, Division of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80 082, 3508 TB Utrecht, The Netherlands. E-mail: [email protected].

DOI: 10.3233/JRS-2009-0465

Journal: International Journal of Risk and Safety in Medicine, vol. 21, no. 1-2, pp. 53-58, 2009