How to compare biologic drugs

Xavier Calvet, Juan Vicente Esplugues

Research output: Contribution to journalArticleResearchpeer-review

3 Citations (Scopus)

Abstract

© 2014 Elsevier España, S.L.U. This consensus document reviews the evidence on the evaluation of biological drugs. The main conclusions of the group are: a) the current evidence on biological comparisons is based on indirect comparisons and is generally unreliable and with important methodological limitations. Therefore, b) it is considered necessary to amend the regulatory directives in the sense of strongly favoring randomized non-inferiority studies comparing face to face the new biological treatment with current standards, avoiding trials versus placebo, c) A key element in this process will be determined by consensus among regulatory agencies, scientific societies, the pharmaceutical industry and health authorities regarding the clinical differences that should be considered relevant in each of the conditions tested.
Original languageEnglish
Pages (from-to)353-359
JournalReumatologia Clinica
Volume10
Issue number6
DOIs
Publication statusPublished - 1 Jan 2014

Keywords

  • Biologic drugs
  • Indirect comparisons
  • Non inferiority studies

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