Sentence examples for this comparability exercise from inspiring English sources

Importantly, if this comparability exercise shows that the biosimilar can be shown to be highly similar for both pharmacokinetic and pharmacodynamic data, without raising any additional safety or efficacy questions that require clinical testing, the EMA does not require clinical efficacy studies 19.

Only copy versions that successfully complete the comparability exercise can be called "biosimilar" [ 2,3].

Approval of biosimilars is contingent on the results of the comparability exercise, which may include quality data, pre-clinical and clinical data, and demonstration of clinical therapeutic equivalence.

The process-related impurities in the drug substance (e.g., host cell protein, DNA) were not part of the comparability exercise because they are specific to the individual process.

Supporters of extrapolation suggest that extrapolation of scientific evidence should be seen as a logical consequence of the comparability exercise principle, which is founded in physiochemical and biological characterization.

Thus, the comparability exercise between the biosimilar trastuzumab and its reference product focused on the physicochemical and functional attributes that have been reported to have an impact on the pharmacokinetic profile (PK) of monoclonal antibodies [ 8] such as charge and glycosylation heterogeneity, aggregates content, and binding affinity to FcRn.

This is achieved through a stepwise comparability exercise that includes in vitro analytical testing, non-clinical comparative testing, and one or more clinical trials [ 8].

Indeed, a subsequent pre-clinical comparability exercise confirmed that GP2013 and originator rituximab are pharmacologically comparable with regard to anti-tumor activity, PK exposure (AUC and Cmax) and B-cell depletion.

Since the aim of biosimilar manufacturing is to produce a molecule highly similar to the reference biologic, a comparability exercise is needed to demonstrate similarity with the reference biologic product based on physicochemical characterization.

A model-based approach testing the hypothesis that the biosimilar PK and/or PK/PD profile is similar to the originator in the target patient population is aligned with the central comparability exercise required for the biosimilar approval.

Such a working database on the product would enable future comparability exercise in support of process upgrade or scale up to support expanding markets or alternative production facility.