Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

ABSTRACT: Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clini

SUBMITTER: Mysler E 

PROVIDER: S-EPMC8578069 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature