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Farmacia Hospitalaria

On-line version ISSN 2171-8695Print version ISSN 1130-6343


CALLEJA-HERNANDEZ, Miguel Ángel; MARTINEZ-SESMERO, José Manuel  and  SANTIAGO-JOSEFAT, Belén. Biosimilars of monoclonal antibodies in inflammatory diseases and cancer: current situation, challenges, and opportunities. Farm Hosp. [online]. 2020, vol.44, n.3, pp.100-108.  Epub Oct 19, 2020. ISSN 2171-8695.

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.

Keywords : Biosimilars; Extrapolation; Interchangeability; Efficiency; Nocebo; Inflammatory diseases; Cancer; Spain.

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