[Translated article] The relevance of therapeutic positioning in the post-approval evaluation of new drugs.

The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties.

The relevance of therapeutic positioning in the post-approval evaluation of new medicines.

The objective of regulatory authorities is to ensure a favorable risk-benefit balance for medicines in their licensed indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licensed indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatments; moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties.

Evolution after switching to biosimilar infliximab in inflammatory bowel disease patients in clinical remission.

Background And Aim: The biosimilar of infliximab (CT-P13) has been approved for the same indications held by the infliximab reference product (Remicade); however, there are few clinical data on switching in inflammatory bowel disease (IBD). The aim of this study was to assess the efficacy, safety, bioavailability profile and factors associated with relapse after switching to biosimilar infliximab in IBD patients in clinical remission.

Material And Method: Observational study with IBD patients treated with Remicade for at least 6 months and in clinical remission for at least 3 months who switched to infliximab biosimilar.

Assessment of off-label prescribing: profile, evidence and evolution.

Objectives: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application.

Methods: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010.

Analysis:  level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.