Posted by Michael Wonder on 12 Oct 2020
Efficacy trials cost more, take longer for biosimilars than originators
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for pivotal studies of originator products, authors report.
Most comparative efficacy trials conducted to obtain FDA approval for a biosimilar had a tendency to be larger, longer, and more costly than clinical trials required for originator products, according to a study of US biosimilar approvals prior to November 2019.
Investigators analysed public records of FDA reviews and approvals of the biologic license applications, clinical trial data from the ClinicalTrials.gov website, and published peer-reviewed articles in this study of the evidence required to prove a biosimilarity claim and costs of Phase 1/3 comparative clinical trials.
