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

The approval pathway for biosimilars of monoclonal antibodies in the European Union is aimed at ruling out the presence of significant  differences with the original biological in quality attributes, efficacy,  immunogenicity and safety. It also provides the rationale for  extrapolating the evidence obtained with a biosimilar in at least one  indication to the rest of the approved indications of its original  biological, thus simplifying the development programme of biosimilars.  Biosimilars of monoclonal antibodies available in the European Union for  the treatment of inflammatory diseases and cancer have fulfilled all the  requirements for approval, and many of them have additional evidence  available. Moreover, real world data confirms the safety and efficacy of  these drugs in the indications they are being used for. In Spain, many  scientific societies endorse the regulatory pathway of biosimilars and  acknowledge their role in the efficiency of the healthcare system. Even  so, some barriers remain that limit their use. The implementation 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. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.