Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara
Indirizzo per corrispondenza: firstname.lastname@example.org
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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