TY - JOUR T1 - Biosimilars: considerations for clinical practice JF - Considerations in Medicine JO - Considerations Med SP - 13 LP - 18 DO - 10.1136/conmed-2017-100005 VL - 1 IS - 1 AU - Valderilio Azevedo AU - Thomas Dörner AU - Robert Strohal AU - John Isaacs AU - Gilberto Castañeda-Hernández AU - João Gonçalves AU - Iain McInnes Y1 - 2017/11/01 UR - http://considerations.bmj.com/content/1/1/13.abstract N2 - With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective. ER -