ARP Rheumatology
ARP Rheumatology

Clinical Practice

ARP Rheumatology Jul/Set 2017 2017; (3) 219-228
Clinical practice, rules or action protocols

The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update


Araújo F, Sepriano A, Teixeira F, Jesus D, Rocha T, Martins P, Tenazinha C, Cordeiro A, Mourão A, Silva C, Vaz C, Duarte C, Ponte C, Santos Fd, Canhão H, Santos H, Pimentão J, Silva Jd, Pereira J, Silva JAd, Miranda L, Oliveira M, Saavedra M, Gonçalves P, Falcão S, Capela S, Fonseca J


Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements. Literature searches on these issues were performed and the search results were presented and discussed in a national meeting. Portuguese rheumatologists considered that affordability should be taken into consideration when initiating a biological drug, but other factors were equally important. In patients already on reference biological treatment, switch to a more affordable biosimilar is desirable, provided a set of conditions is rigorously met. Automatic substitution is not acceptable and current evidence is insufficient to support interchangeability. Extrapolation of clinical indications is endorsed by Portuguese rheumatologists, and the statements on safety, pharmacovigilance and traceability are in accordance with the previous position paper.







Filipe Araújo, Alexandre Sepriano, Filipa Teixeira, Diogo Jesus, Teresa Rocha, Patrícia Martins, Catarina Tenazinha, Ana Cordeiro, Ana Mourão, Cândida Silva, Carlos Vaz, Cátia Duarte, Cristina Ponte, Fernando dos Santos, Helena Canhão, Helena Santos, José Pimentão, José da Silva, Joaquim Pereira, José António da Silva, Luís Miranda, Margarida Oliveira, Maria Saavedra, Pedro Gonçalves, Sandra Falcão, Susana Capela, João Fonseca. The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update. ARP, nº3, Jul/Set 2017:219-228. PMID: 28894080
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