title: Effective pharmaceutical regulation needs alignment with doctors.
abstract: Concerns emanating from the medical community about the safety and efficacy of biosimilars indicate an increasing distrust of the outcome of the drug regulatory process. To illustrate this, we analysed the creation of the European biosimilar regulatory framework, specifically focussing on the guidelines outlining approval criteria for biosimilar erythropoietins, which have been recently adopted. We observed an absence of the organised medical community in the public process of creating and updating the guidelines. In this article we argue that, to ensure that innovative medicines continue to find their way to the patients who might benefit from them, a closer collaboration between the organised medical community and regulators is needed.
authors: Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, P.O. Box 80082, 3508 TB Utrecht, The Netherlands.
authors: Hans C
authors: HC
authors: Ebbers
authors: Toine
authors: T
authors: Pieters
authors: Hubert G
authors: HG
authors: Leufkens
authors: Huub
authors: H
authors: Schellekens
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003299:Cooperative Behavior; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D010820:Physicians / Q000458:organization & administration
chemical_list: D059451:Biosimilar Pharmaceuticals; D004921:Erythropoietin