Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.

ABSTRACT: Biosimilars are increasingly available for the treatment of many serious disorders, however some concerns persist about switching a patient to a biosimilar whose condition is stable while on the reference biologic. Randomized controlled studies and extension studies with a switch treatment period (STP) to or from a biosimilar and its reference biologic were identified from publicly available information maintained by the U.S. Food and Drug Administration (FDA). These findings were augmented with data from peer reviewed publications containing information not captured in FDA reviews. Forty-four STPs were identified from 31 unique studies for 21 different biosimilars. Data were extracted and synthesized following PRISMA guidelines. Meta-analysis was conducted to estimate the overall risk dif

SUBMITTER: Herndon TM 

PROVIDER: S-EPMC10547155 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature