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The Portuguese Society of Rheumatology position paper on the use of biosimilars

2014Journal article Open access
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dc.contributor.authorFonseca, JE
dc.contributor.authorGonçalves, J
dc.contributor.authorAraújo, F
dc.contributor.authorCordeiro, I
dc.contributor.authorTeixeira, F
dc.contributor.authorCanhão, H
dc.contributor.authorPereira da Silva, JA
dc.contributor.authorGarcês, S
dc.contributor.authorMiranda, LC
dc.contributor.authorRamiro, Sofia
dc.contributor.authorRoxo, Ana
dc.contributor.authorPimentel-Santos, FM
dc.contributor.authorTavares, V
dc.contributor.authorNeto, A
dc.contributor.authorSepriano, A
dc.contributor.authorMalcata, A
dc.contributor.authorFaustino, A
dc.contributor.authorSilva, C
dc.contributor.authorAmbrósio, C
dc.contributor.authorDuarte, C
dc.contributor.authorMiguel, C
dc.contributor.authorBarcelos, F
dc.contributor.authorSantos, H
dc.contributor.authorCunha, I
dc.contributor.authorRamos, JC
dc.contributor.authorMelo-Gomes, JA
dc.contributor.authorPimentão, JB
dc.contributor.authorCosta, L
dc.contributor.authorMaurício, L
dc.contributor.authorSilva, M
dc.contributor.authorBernardes, M
dc.contributor.authorBogas, M
dc.contributor.authorCoelho, PC
dc.contributor.authorMonteiro, P
dc.contributor.authorAguiar, R
dc.contributor.authorAndré, R
dc.contributor.authorLeitão, R
dc.contributor.authorPimenta, S
dc.contributor.authorMeirinhos, T
dc.contributor.authorFernandes, S
dc.contributor.authorLas, V
dc.contributor.authorCastelão, W
dc.date.accessioned2017-09-01T13:41:05Z
dc.date.available2017-09-01T13:41:05Z
dc.date.issued2014
dc.description.abstractBiotechnological 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationActa Reumatol Port. 2014 Jan-Mar;39(1):60-71.pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.4/2100
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.subjectDoenças Reumáticaspt_PT
dc.subjectMedicamentos Biossimilarespt_PT
dc.titleThe Portuguese Society of Rheumatology position paper on the use of biosimilarspt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.startPage60-71pt_PT
oaire.citation.volume39pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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