The phrase "a comparability exercise" is correct and usable in written English.
It can be used in contexts where you are discussing an assessment or evaluation that compares different items, entities, or data points.
Example: "The team conducted a comparability exercise to evaluate the performance of various marketing strategies."
Alternatives: "a benchmarking analysis" or "a comparison assessment".
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.
Importantly, only copies of biologics that have undergone a comparability exercise and have been approved by a regulatory body can be called "biosimilar" [ 5].
Once the patent for a biologic expires, biosimilars can be developed, tested, and introduced into the market, after approval by regulatory agencies on the basis of a comparability exercise [ 2].
Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using a hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact on its pharmacokinetics, pharmacodynamics, and immunogenicity.
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].
The term biosimilars was coined to describe any copy of an authorized branded biologic originator that has demonstrated similarity in a rigorous comparability exercise [ 3].
A biosimilar demonstrates similarity to the reference medicinal product in terms of quality characteristics, biological, activity, safety and efficacy) based on a comprehensive comparability exercise" [ 3].
A thorough physicochemical and functional comparability exercise is a key element in demonstrating biosimilarity.
A thorough physicochemical and functional comparability exercise serves as a foundation for the subsequent demonstration of biosimilarity in further pre-clinical and clinical trials.
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.
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.
