title: Risk management of biosimilars in oncology: each medicine is a work in progress.
abstract: Drug licensing and drug safety monitoring for standard chemical entities have been established and are routinely used. These have resulted in a solid foundation of knowledge from which confident therapeutic decisions can be made. For many chemical entities, this advanced level of experience is also present for the generic products. The expertise surrounding the development of biosimilar competitor versions is increasing and progress is encouraging. To address the re-engineering and comparability complexities of biosimilars, the European Union imposed a requirement that risk management plans be included in the medications' marketing applications. This paper summarizes and discusses the circumstances complicating the public's view of drug safety, historical incidents during the transition from innovative to competitor products, as well as retrospective assessments of the development and post-marketing experiences thus far with two biosimilars. Through assessing the market entries and post-marketing experiences of biosimilars used in oncology, the healthcare field can better prepare for the next wave of comparator-products: biosimilar monoclonal antibodies.
authors.affiliation: Hospital Pharmacy, Erasmus University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands. a.vulto@erasmusmc.nl
authors.forename: Arnold G
authors.initials: AG
authors.lastname: Vulto
authors.forename: Stacy A
authors.initials: SA
authors.lastname: Crow
mesh_terms: D001688:Biological Products / Q000493:pharmacokinetics*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D012308:Risk Management; D013810:Therapeutic Equivalency; D014018:Tissue Distribution
chemical_list: D001688:Biological Products