title: [The patents game. Generic and biosimilar drugs].
abstract: The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use.
authors.affiliation: Servicio de Farmacia, Hospital Universitario La Paz, IdiPAZ , Madrid, España. Electronic address: evillabueno@telefonica.net.
authors.forename: E
authors.initials: E
authors.lastname: Villamañán
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Ministerio de Sanidad Política Social e Igualdad, Madrid, España.
authors.forename: D
authors.initials: D
authors.lastname: González
authors.affiliation: Servicio de Cardiología, Hospital Universitario La Paz, IdiPAZ , Madrid, España.
authors.forename: E
authors.initials: E
authors.lastname: Armada
authors.affiliation: Servicio de Farmacia, Hospital Universitario La Paz, IdiPAZ , Madrid, España.
authors.forename: M
authors.initials: M
authors.lastname: Ruano
authors.affiliation: Servicio de Neumología, Hospital Universitario La Paz, IdiaPAZ, Madrid, España.
authors.forename: R
authors.initials: R
authors.lastname: Álvarez-Sala
authors.affiliation: Servicio de Farmacia, Hospital Universitario La Paz, IdiPAZ , Madrid, España.
authors.forename: A
authors.initials: A
authors.lastname: Herrero
mesh_terms: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic; D006801:Humans; D010330:Patents as Topic
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic
keywords: Biosimilar; Biosimilares; Drugs generic; Efficiency; Eficiencia; Medicamentos genéricos; Normativa; Patent; Patente; Regulation