Key words: Biosimilars, Comparability, Ethics of drug use, Drug cost
The physico-chemical properties of biotechnological drugs are tightly linked to their manufacturing
process. Yet, pharmaceutical companies that wish to make important manufacturing
changes to their process may do so as long as they follow ICHQ5E guidelines
and the change is approved by their local regulatory authority. This guidelines state that
a head-to-head comparability exercise on quality must be executed and if this is deemed
insufficient, the applicant is also required to perform preclinical and clinical studies. These
very same principles apply to the approval pathway of biosimilars, i.e. biotechnological
products that are commercialized after the patent expiry of the reference drug. Indeed,
biosimilars always need to perform clinical head-to-head comparisons. Given these
premises, it is obvious that biosimilars are as safe and effective as the reference product
but, via competition, reduce the costs of the National Health systems.
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