Online first

Acta Reumatológica Portuguesa - Online First: 2017-07-21
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.