title: Position paper from the Spanish Society of Rheumatology on biosimilar drugs.
abstract: A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs.
authors.affiliation: FEA Reumatología, Hospital Virgen del Puerto, Plasencia, Cáceres, España. Electronic address: miguel.abad@telefonica.net.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Abad Hernández
authors.affiliation: Servicio de Reumatología, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, España.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Andreu
authors.affiliation: Servicio de Reumatología, Hospital Universitario Reina Sofía, Córdoba, España.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Caracuel Ruiz
authors.affiliation: Sección de Reumatología, Hospital General Universitario de Castellón, Castellón de la Plana, España.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Belmonte Serrano
authors.affiliation: Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Laguna, San Cristóbal de La Laguna, Santa Cruz de Tenerife, España; Servicio de Reumatología, Hospital Universitario de Canarias, San Cristóbal de La Laguna, Santa Cruz de Tenerife, España.
authors.forename: Federico
authors.initials: F
authors.lastname: Díaz-González
authors.affiliation: Servicio de Reumatología, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: José Vicente
authors.initials: JV
authors.lastname: Moreno Muelas
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012219:Rheumatology; D012955:Societies, Medical; D013030:Spain
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals
keywords: Biosimilares; Biosimilars; Posicionamiento; Position paper; Review; Revisión; Sociedad Española de Reumatología; Spanish Society of Rheumatology