Biosimilars: Adoption Of Global Reference Comparator Would Eliminate Bridging Studies

07 Aug 2017

Bridging studies conducted between local and foreign versions of the same reference product are redundant, costly and not scientifically necessary for biosimilar development, consultants Christopher Webster and Gillian Woollett write; authors suggest three criteria for global acceptance of a single comparator.

Analytical and clinical pharmacokinetic bridging studies between local and foreign versions of the same reference biologic are redundant, costly, scientifically unnecessary for biosimilar development and should be eliminated as a regulatory requirement, according to a recent journal article.

Christopher Webster and Gillian Woollett argue the case for adoption of a “global reference comparator,” whereby a single approved version...