title: The Portuguese Society of Rheumatology position paper on the use of biosimilars.
abstract: Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.
authors.forename: João Eurico
authors.initials: JE
authors.lastname: Fonseca
authors.forename: João
authors.initials: J
authors.lastname: Gonçalves
authors.forename: Filipe
authors.initials: F
authors.lastname: Araújo
authors.forename: Inês
authors.initials: I
authors.lastname: Cordeiro
authors.forename: Filipa
authors.initials: F
authors.lastname: Teixeira
authors.forename: Helena
authors.initials: H
authors.lastname: Canhão
authors.forename: José António Pereira
authors.initials: JA
authors.lastname: da Silva
authors.forename: Sandra
authors.initials: S
authors.lastname: Garcês
authors.forename: Luís Cunha
authors.initials: LC
authors.lastname: Miranda
authors.forename: Sofia
authors.initials: S
authors.lastname: Ramiro
authors.forename: Ana
authors.initials: A
authors.lastname: Roxo
authors.forename: Fernando M
authors.initials: FM
authors.lastname: Pimentel-Santos
authors.forename: Viviana
authors.initials: V
authors.lastname: Tavares
authors.forename: Adriano
authors.initials: A
authors.lastname: Neto
authors.forename: Alexandre
authors.initials: A
authors.lastname: Sepriano
authors.forename: Armando
authors.initials: A
authors.lastname: Malcata
authors.forename: Augusto
authors.initials: A
authors.lastname: Faustino
authors.forename: Cândida
authors.initials: C
authors.lastname: Silva
authors.forename: Catarina
authors.initials: C
authors.lastname: Ambrósio
authors.forename: Cátia
authors.initials: C
authors.lastname: Duarte
authors.forename: Cláudia
authors.initials: C
authors.lastname: Miguel
authors.forename: Filipe
authors.initials: F
authors.lastname: Barcelos
authors.forename: Helena
authors.initials: H
authors.lastname: Santos
authors.forename: Inês
authors.initials: I
authors.lastname: Cunha
authors.forename: João Carlos
authors.initials: JC
authors.lastname: Ramos
authors.forename: José António Melo
authors.initials: JA
authors.lastname: Gomes
authors.forename: José Bravo
authors.initials: JB
authors.lastname: Pimentão
authors.forename: Lúcia
authors.initials: L
authors.lastname: Costa
authors.forename: Luís
authors.initials: L
authors.lastname: Maurício
authors.forename: Margarida
authors.initials: M
authors.lastname: Silva
authors.forename: Miguel
authors.initials: M
authors.lastname: Bernardes
authors.forename: Mónica
authors.initials: M
authors.lastname: Bogas
authors.forename: Paulo Clemente
authors.initials: PC
authors.lastname: Coelho
authors.forename: Paulo
authors.initials: P
authors.lastname: Monteiro
authors.forename: Renata
authors.initials: R
authors.lastname: Aguiar
authors.forename: Rui
authors.initials: R
authors.lastname: André
authors.forename: Rui
authors.initials: R
authors.lastname: Leitão
authors.forename: Sofia
authors.initials: S
authors.lastname: Pimenta
authors.forename: Tiago
authors.initials: T
authors.lastname: Meirinhos
authors.forename: Susana
authors.initials: S
authors.lastname: Fernandes
authors.forename: Vera
authors.initials: V
authors.lastname: Las
authors.forename: Walter
authors.initials: W
authors.lastname: Castelão
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D012216:Rheumatic Diseases / Q000188:drug therapy*
chemical_list: D059451:Biosimilar Pharmaceuticals