Posted by Michael Wonder on 21 Sep 2020
UK regulators contend biosimilar efficacy trials are redundant
19 September 2020 - Comparative biosimilar efficacy trials are unnecessary to demonstrate that drug candidates are equivalent to reference products, authors of an analysis argue in a new paper.
The group from the UK’s Medicines and Healthcare Products Regulatory Agency contends that, except in extreme cases, analytical testing and a pharmacokinetic trial are sufficient to demonstrate biosimilarity.
They propose a streamlined approval process for biosimilars to accelerate patient access, in which “efficacy trials are reserved for exceptional circumstances.”
