Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.

ABSTRACT:

Background

Biosimilar versions of widely prescribed drugs, including the tumour-necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non-inferior to a reference product after multiple switches between products.

Aims

To investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, r

SUBMITTER: Feagan BG 

PROVIDER: S-EPMC6587715 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature