Biosimilars in rheumatology: the wind of change

A recent publication suggested that licensed biologics undergo changes in relevant molecular attributes over time. 10 In fact, the seminal regulatory guideline ICH Q5E, issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 11 an internationally agreed standard that sets the data requirements for changes to the manufacturing process for biotechnological and biological products, stipulates that "The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product". [...]all of the licensed mAbs and -cept fusion proteins used in rheumatology have had changes in their manufacturing processes after their initial approval ( figure 1 A).