Biosimilars of monoclonal antibodies in inflammatory diseases and cancer: current situation, challenges, and opportunities.

Abstract

The approval pathway for biosimilars of monoclonal antibodies in theEuropeanUnion is aimed at ruling out the presence of significant differenceswith the original biological in quality attributes, efficacy, immunogenicityand safety. It also provides the rationale for extrapolating the evidenceobtained with a biosimilar in at least one indication to the rest of theapproved indications of its original biological, thus simplifying the developmentprogramme of biosimilars. Biosimilars of monoclonal antibodiesavailable in the European Union for the treatment of inflammatory diseasesand cancer have fulfilled all the requirements for approval, and manyof them have additional evidence available. Moreover, real world dataconfirms the safety and efficacy of these drugs in the indications they arebeing used for. In Spain, many scientific societies endorse the regulatorypathway of biosimilars and acknowledge their role in the efficiency of thehealthcare system. Even so, some barriers remain that limit their use. Theimplementation of different measures at the patient, prescriber, institutional, and national levels might increase the penetration of biosimilars, freeing up resources that may be invested in other therapies and, potentially, boost innovation.