title: Is it time for biosimilars in autoimmune diseases?
abstract: The last two decades have witnessed a revolution in the treatment of autoimmune diseases due to the introduction of biological agents which, although now included as standard treatment in patients with autoimmune rheumatological, dermatological and gastrointestinal diseases. The use of biological agents is associated with greater costs compared with the mainly anti-inflammatory and immunosuppressant drugs used in the pre-biological era. Biosimilars are highly similar copies of biological drugs, but not identical to approved 'reference' agents. Biological agents are complex proteins involved in the immune response and their exact replicas are extremely difficult, if not impossible, to obtain. Three scenarios have converged to provide a specific opportunity for biosimilars in autoimmune diseases: growing demand for biologics due to successful clinical use; the nearing of patent expiry for the four top-selling biological brands; and the search to reduce health costs due to the financial crisis. We aimed to review the crucial topics of efficacy, safety and regulatory approach of upcoming biosimilars.
authors.affiliation: Louise Coote Lupus Unit, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK. mjcuadrado@yahoo.com
authors.forename: Maria-Jose
authors.initials: MJ
authors.lastname: Cuadrado
authors.forename: Savino
authors.initials: S
authors.lastname: Sciascia
authors.forename: Xavier
authors.initials: X
authors.lastname: Bosch
authors.forename: Munther A
authors.initials: MA
authors.lastname: Khamashta
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos-Casals
mesh_terms: D001327:Autoimmune Diseases / Q000188:drug therapy*; D001688:Biological Products / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000191:economics / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D010330:Patents as Topic
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals