The Portuguese Society of Rheumatology position paper on the use of biosimilars
Authors
João Eurico Fonseca, João Gonçalves, Filipe Araújo, Inês Cordeiro, Filipa Teixeira, Helena Canhão, José António Pereira da Silva, Sandra Garcês, Luís Cunha Miranda, Sofia Ramiro, Ana Roxo, Fernando M. Pimentel-Santos, Viviana Tavares, Adriano Neto, Alexandre Sepriano, Armando Malcata, Augusto Faustino, Cândida Silva, Catarina Ambrósio, Cátia Duarte, Cláudia Miguel, Filipe Barcelos, Helena Santos, Inês Cunha, João Carlos Ramos, José António Melo Gomes, José Bravo Pimentão, Lúcia Costa, Luís Maurício, Margarida Silva, Miguel Bernardes, Mónica Bogas, Paulo Clemente Coelho, Paulo Monteiro, Renata Aguiar, Rui André, Rui Leitão, Sofia Pimenta, Tiago Meirinhos, Susana Fernandes, Vera Las, Walter Castelão on behalf of Sociedade Portuguesa de Reumatologia
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
effica cy 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 systema tic
literature reviews were performed, one concerning cli -
nical 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 appro -
ved by Portuguese rheumatologists. Briefly, this position
statement is contrary to automatic substitution of
the originator by the biosimilar, defends either a diffe -
rent 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 di -
seases and/or age groups without adequate pre-clinical,
safety or efficacy data.
Section:
Clinical Practice