Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example.

ABSTRACT: The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on current guidance. In order to demonstrate similarity of a biosimilar product versus the originator (ie, the branded product), based on regulatory guidance, a stepwise approach is usually taken, starting with a comprehensive structural and functional characterisation of the new biological moiety. Given the sequential nature of the review process, the extent and nature of the non-clinical in vivo studies a

SUBMITTER: Lai Z 

PROVIDER: S-EPMC4746581 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature