Biosimilars and Reference Biologics: Decisions on Biosimilar Interchangeability Require the Involvement of Dermatologists

On September 13, 2013, the European Medicines Agency (EMA) approved the first biosimilar a and treatment of moderate to severe psoriasis will be one of the indications.Undoubtedly this important news for dermatologists will have a major impact on prescribing patterns and management of patients with moderate to severe psoriasis.On June 27, 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended that the EMA approve Inflectra (the applicant was Hospira UK) and Remsima (the applicant was Celltrion Healthcare Hungary Kft). 1 These biosimilars (CT-P13, Remsima) have already been approved in South Korea. 2 The 2 manufacturers (Celltrion and Hospira) have reached an agreement to market 8 biosimilars in the United States, Europe, Canada, Australia, and New Zealand.The active substance in both cases is infliximab, and both are biological medicinal products, similar to the reference product Remicade (infliximab), approved in the European Union since August 13, 1999.Published studies suggest that both products have a quality, safety, and efficacy profile similar to Remicade (infliximab).Thus the clinical trials PLANETRA 3 and PLANETAS 4 were able to show comparable efficacy to the innovator reference product infliximab in the treatment of ଝ Please cite this article as: Puig L. Biosimilares y biológicos de referencia: la intercambiabilidad de los biosimilares requiere la participación del dermatólogo.Actas Dermosifiliogr.2014;105:435---437.