Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars.
Rishi J DesaiSeoyoung C KimJeffrey R CurtisJaclyn L F BoscoBernadette EichelbergerCharles E BarrCatherine M LockhartBrian D BradburyJerry ClewellHillel P CohenJoshua J Gagnenull nullPublished in: Pharmacoepidemiology and drug safety (2019)
Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.