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Biosimilarity Evaluations Should Be More Tailored


A peer-reviewed study suggested that comparative efficacy trials are not always needed to determine efficacy equivalence for biosimilars, as data from pharmacokinetic (PK) studies and in vitro functional assays may suffice.

A new study suggests that the scientific review process for biosimilars should be customized, because comparative efficacy trials are not always useful in determining biosimilarity when other data exists.1

The study from experts with the International Generic and Biosimilar Medicines Association’s (IGBA) Biosimilar Committee, is the group’s first peer-reviewed scientific paper on biosimilar medicines development.

“Considering the remaining global access needs in biologic therapies, IGBA considers the tailoring of clinical biosimilar development a significant and achievable step in fostering earlier and broader access to safe and effective biologic therapies in the future,” said IGBA chair, Hanan Sboul, in a statement.2

Currently, comparative efficacy studies are costly for manufacturers and are expected by the European Medicines Agency (EMA) and the FDA to confirm biosimilarity of products, especially in cases where suitable pharmacodynamic (PD) markers used in assessing PK studies aren’t available.

“Although a PD biomarker study can be a useful confirmation of biosimilarity, it represents an earlier measure of a clinical physiological response that is required for efficacy and therefore serves the same purpose as a comparative efficacy trial,” authors said.

In the study, comparative efficacy studies were able to prove similar efficacy to originator products 100% of the time; however, these studies provided no added value in 95% of the biosimilar development plans that were examined.

The remaining 5% of development programs showed that despite meeting efficacy outcomes, candidates exhibited differences in immunogenicity and required changes to the manufacturing process as well as additional clinical studies before approval.

This issue occurred in only 2 cases and has not been observed since 2010. The authors noted that “considering today’s state-of-the-art assays and control strategies, a repetition of these 2 cases is unlikely.”

In cases where comparative efficacy tests are not necessary, the authors recommend that requirements should be waived, and agencies should instead rely on data from analytical and in vitro functional assays as well as PK equivalence studies that assess immunogenicity.

Study authors noted that this approach could apply to complex proteins including monoclonal antibodies and will not jeopardize the regulatory standards in either the European Union (EU) or the United States.

Erika Satterwhite, chair of the IGBA Biosimilar Committee said that the study “clearly articulates the imperative for a tailored clinical biosimilar development paradigm. ... that is founded on scientific evidence and compatible with both existing EU and US biosimilar regulatory standards.”


1. Schiestl M, Ranganna G, Watson K, et al. The path towards a tailored clinical biosimilar development [published online April 7, 2020]. BioDrugs. doi: 10.1007/s40259-020-00422-1.

2. IGBA contributes to global discussion on tailored clinical biosimilar development with new peer-reviewed scientific paper [press release]. Geneva, CH: IGBA; April 10, 2020. igbamedicines.org/doc/20200410_IGBA%20PR-CT%20tailoring-BioDrugs-final-bis%20clean.pdf. Accessed April 20, 2020.

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