Editorial
Biosimilars, a new era in rheumatology in Spain
Los biosimilares, una nueva era en la reumatología en España
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"Rafael Cáliz Cáliz, Petra Díaz del Campo Fontecha, María Galindo Izquierdo, Francisco Javier López Longo, María Ángeles Martínez Zamora, Amparo Santamaria Ortiz, Olga Amengual Pliego, María José Cuadrado Lozano, María Paloma Delgado Beltrán, Loreto Carmona Ortells, Evelin Cecilia Cervantes Pérez, Gisela Díaz-Cordovés Rego, Sandra Garrote Corral, Clara Fuego Varela, María Martín López, Betina Nishishinya, Marta Novella Navarro, Claudia Pereda Testa, Hiurma Sánchez Pérez, Lucia Silva-Fernández, Víctor Manuel Martínez Taboada" "autores" => array:21 [ 0 => array:2 [ "nombre" => "Rafael" "apellidos" => "Cáliz Cáliz" ] 1 => array:2 [ "nombre" => "Petra" "apellidos" => "Díaz del Campo Fontecha" ] 2 => array:2 [ "nombre" => "María" "apellidos" => "Galindo Izquierdo" ] 3 => array:2 [ "nombre" => "Francisco Javier" "apellidos" => "López Longo" ] 4 => array:2 [ "nombre" => "María Ángeles" "apellidos" => "Martínez Zamora" ] 5 => array:2 [ "nombre" => "Amparo" "apellidos" => "Santamaria Ortiz" ] 6 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"paginaInicial" => "131" "paginaFinal" => "132" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Federico Díaz-González, Sagrario Bustabad-Reyes" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Federico" "apellidos" => "Díaz-González" "email" => array:1 [ 0 => "federico.diaz.gonzalez@gmail.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Sagrario" "apellidos" => "Bustabad-Reyes" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servicio de Reumatología, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Tenerife, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departamento de Medicina, Dermatología y Psiquiatría, Universidad de La Laguna, Santa Cruz de Tenerife, Tenerife, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Los biosimilares, una nueva era en la reumatología en España" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Since their introduction almost 2 decades ago, biologic drugs have proven to be highly effective tools for the treatment of patients with inflammatory chronic rheumatic diseases<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> which respond poorly to conventional disease-modifying antirheumatic drugs (DMARDS).<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a> Despite their ability to improve the quality of life of many of these patients, the high cost of these drugs, which is due to the complexity of their development and production,<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">3</span></a> has limited their commonplace usage.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">4</span></a> It is expected that the drop in prices stimulated by competition from the arrival of biosimilar drugs will encourage the use of biologics in earlier stages of diseases, on the one hand, and on the other, will lead to greater equity in their availability.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">5</span></a> Although we are unaware of specific cases, we frankly do not believe there is any general inequity of biologic drug availability in the Spanish health system.</p><p id="par0010" class="elsevierStylePara elsevierViewall">A biosimilar is a biologic drug which contains a version of the active substance of an original biologic agent that has already been approved (benchmark product), and which may be used in the same way, and through extrapolation, under the same indications as the product it imitates. For their approval, biosimilars were subjected to “head to head” clinical trials against their benchmark product, where they had to demonstrate that their safety and efficacy profile was indistinguishable from that of the drug they were compared with. Nowadays in Spain biosimilars of infliximab, etanercept, rituximab and adalimumab are available and it is highly likely that new biosimilars of these and other biologics prescribed for rheumatic diseases will be available in the near future. <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the biosimilars of these molecules which have been approved up until now by the European Medicines Agency (EMA) and which ones are available in Spain.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">For some time, the biosimilar market has been under pressure to reduce prices. This trend began in Northern countries and has extended to the United Kingdom, France, Germany, Italy and Spain. This has led manufacturers of biosimilars to offer discounts of up to 70% compared with the originator agent, although with significant variations both between countries and within the same country. This policy has pushed companies producing originator agents to reduce prices in order to retain their market, leading to a highly significant drop in the cost per patient of biologic drugs that have biosimilars. Furthermore, the Spanish Society of Rheumatology (SSR) has stated its unequivocal alignment with the sustainability of the healthcare systems and has shown its preference for the use of therapies at a lower cost when they have been proven to be comparable in efficacy and safety to the more expensive alternatives.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The arrival of many biosimilars of products with which rheumatologists are familiarized and with unimaginable prices from only just 6 months ago will impact the prescription habits of biologics in rheumatology. A new era is already upon us and will present new challenges for the rheumatologists:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1.</span><p id="par0025" class="elsevierStylePara elsevierViewall">The arrival of all these new molecules fortifies the need to prescribe biologics by their trade name in order to ensure their traceability. Different countries have adopted different approaches to guarantee accurate traceability of biologic products. The EU approved legislation which enforces the recording of the trade name and lot number, <a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a> whilst U.S.A. and Japan have continued to use specific non registered names. This fact has resulted in the name of biosimilars becoming complex and inconsistent on a worldwide level. It is essential that all biologic products can be identified with a single name. This applies to both biosimilars and the original products and is particularly important for prescription, traceability of the product and pharmacovigilance. As a result, the prescription of biologics including biosimilars must always be made with the trade name.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2.</span><p id="par0030" class="elsevierStylePara elsevierViewall">As several biologics exist with biosimilars and also several biosimilars exist with the same benchmark molecule, this increases the complexity of names to be remembered, which may lead to the possibility of error.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3.</span><p id="par0035" class="elsevierStylePara elsevierViewall">As we have already commented upon, during the last few months in many autonomous communities in Spain highly aggressive price policies have appeared where several biosimilars have been on offer at a price 4 times lower than the benchmark product, positioning the DMARDS price range to that of subcutaneous methotrexate. This is in itself good news, and will undoubtedly impact current prescription habits of rheumatologists today. On the one hand there will logically be a prioritization of the prescription of biosimilars in patients who are biologic naïve, compared to the prescription of their original innovators and also to other molecules with different targets, be they biologics or not, which are accepted as first line treatment. On the other hand, this price reduction policy will increase the pressure by health managers on rheumatologists to exchange originator biological agents with biosimilars in patients with a good clinical response. In this respect the prevailing law in Spain impedes the replacement by the hospital pharmacists of biologic products and the Spanish Society of Rheumatology (SSR), in its latest positioning on biosimilars<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a> defends that the exchange of a biologic for its biosimilar may only be made by the prescribing physician and that this exchange is accepted only in the case of patients in a stable condition. In any event, the SSR states that this should be an individualized decision made with the patient's consent.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">4.</span><p id="par0040" class="elsevierStylePara elsevierViewall">Current commercial aggressiveness may lead hospital pharmacies to change to biosimilars of the same molecule over time, and may lead to hospital managers recommending exchange between biosimilars with the same originator agent. These situations should be carefully analyzed since: (1) there are no studies to endorse the safety and effectiveness of exchange between biosimilars; (2) this complicates product traceability; (3) it encourages a market-based vision of medicine; and (4) it supports the concept that biosimilars are genetic products, which is not the case.</p></li></ul></p><p id="par0045" class="elsevierStylePara elsevierViewall">Substantial cost savings may undoubtedly be made if patients who are “naive” to biologics begin treatment with biosimilars. In patients who are already being treated with biologics and who show good response to them, changing to a biosimilar may be another source of saving, but any harmful effect in these circumstances must be taken into account. This effect may be responsible for a subjective increase in disease activity which would lead to lack of adherence. We believe optimum conditions for changing to biosimilars in patients with a biological treatment include: remission or low activity, rapid response (under 6 months) and as first or second line treatment.</p><p id="par0050" class="elsevierStylePara elsevierViewall">In order to guarantee optimum and rational integration of biosimilars within rheumatology practice and to take advantage of their cost-saving opportunities, rheumatologists have to be aware that truthful information to our patients on cost-saving, efficacy and safety of biosimilars is the key to ensuring their usage long term. We understand that the course of action with the highest impact for the rational use of biosimilars is recognition by doctors, patients and healthcare authorities of the need to generate savings for the sustainment of our health system. Only from dialogue based on knowledge and comprehension towards patient sensitivity can rational and consensual usage of biologics and biosimilars be made in this new upcoming era.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financing</span><p id="par0055" class="elsevierStylePara elsevierViewall">No financing was received for this study.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Financing" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Díaz-González F, Bustabad-Reyes S. Los biosimilares, una nueva era en la reumatología en España. Reumatol Clín. 2020;16:131–132.</p>" ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">EMA: European Medicines Agency.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Active substance \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Trade name \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Approved by the EME \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Currently available in Spain \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Etanercept \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Benepali® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14/01/16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Erelzi® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23/06/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Adalimumab \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Amgevita® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22/03/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Halimatoz® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/07/18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hefiya® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/07/18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hulio® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17/09/18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hyrimoz® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/07/18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Idacio® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">02/04/19 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Imraldi® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24/08/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Kromeya® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">02/04/19 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Infliximab \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Flixabi® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/05/16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Inflectra® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10/09/13 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Remsina® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10/09/13 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Zessly® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">18/05/18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Rituximab \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Blitzima® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13/07/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Ritemvia® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13/07/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Rituzena® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13/07/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Rixathon® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15/06/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Riximyo® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15/06/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Truxima® \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17/02/17 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Yes \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2287788.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Dates of approval by the EME of biosimilar drugs prescribed in rheumatology and their availability in Spain.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J.S. Smolen" 1 => "R. Landewe" 2 => "J. Bijlsma" 3 => "G. Burmester" 4 => "K. Chatzidionysiou" 5 => "M. Dougados" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/annrheumdis-2016-210715" "Revista" => array:6 [ "tituloSerie" => "Ann Rheum Dis" "fecha" => "2017" "volumen" => "76" "paginaInicial" => "960" "paginaFinal" => "977" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28264816" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0045" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J.L. Nam" 1 => "K. Takase-Minegishi" 2 => "S. Ramiro" 3 => "K. Chatzidionysiou" 4 => "J.S. Smolen" 5 => "D. van der Heijde" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/annrheumdis-2016-210713" "Revista" => array:6 [ "tituloSerie" => "Ann Rheum Dis" "fecha" => "2017" "volumen" => "76" "paginaInicial" => "1113" "paginaFinal" => "1136" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28283512" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0050" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Conquering the complexities of biologics to get to biosimilars" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "E. Palmer" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:2 [ "tituloSerie" => "Fierce Pharma" "fecha" => "2013" ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0055" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Biosimilars for the management of rheumatoid arthritis: economic considerations" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "L. Gulacsi" 1 => "V. Brodszky" 2 => "P. Baji" 3 => "H. Kim" 4 => "S.Y. Kim" 5 => "Y.Y. Cho" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1586/1744666X.2015.1090313" "Revista" => array:7 [ "tituloSerie" => "Expert Rev Clin Immunol" "fecha" => "2015" "volumen" => "11" "numero" => "Suppl 1" "paginaInicial" => "S43" "paginaFinal" => "S52" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26395836" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0060" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J. Kay" 1 => "M.M. Schoels" 2 => "T. Dorner" 3 => "P. Emery" 4 => "T.K. Kvien" 5 => "J.S. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 10 | 10 | 20 |
| 2024 October | 92 | 25 | 117 |
| 2024 September | 102 | 22 | 124 |
| 2024 August | 124 | 34 | 158 |
| 2024 July | 113 | 25 | 138 |
| 2024 June | 91 | 30 | 121 |
| 2024 May | 97 | 26 | 123 |
| 2024 April | 92 | 22 | 114 |
| 2024 March | 79 | 24 | 103 |
| 2024 February | 81 | 33 | 114 |
| 2024 January | 64 | 26 | 90 |
| 2023 December | 64 | 23 | 87 |
| 2023 November | 69 | 29 | 98 |
| 2023 October | 74 | 26 | 100 |
| 2023 September | 88 | 36 | 124 |
| 2023 August | 98 | 23 | 121 |
| 2023 July | 72 | 19 | 91 |
| 2023 June | 52 | 23 | 75 |
| 2023 May | 76 | 27 | 103 |
| 2023 April | 110 | 11 | 121 |
| 2023 March | 106 | 26 | 132 |
| 2023 February | 65 | 28 | 93 |
| 2023 January | 59 | 27 | 86 |
| 2022 December | 64 | 29 | 93 |
| 2022 November | 54 | 32 | 86 |
| 2022 October | 66 | 32 | 98 |
| 2022 September | 44 | 20 | 64 |
| 2022 August | 31 | 37 | 68 |
| 2022 July | 54 | 33 | 87 |
| 2022 June | 39 | 33 | 72 |
| 2022 May | 53 | 44 | 97 |
| 2022 April | 70 | 39 | 109 |
| 2022 March | 54 | 51 | 105 |
| 2022 February | 62 | 37 | 99 |
| 2022 January | 59 | 32 | 91 |
| 2021 December | 61 | 34 | 95 |
| 2021 November | 45 | 40 | 85 |
| 2021 October | 55 | 44 | 99 |
| 2021 September | 44 | 41 | 85 |
| 2021 August | 42 | 32 | 74 |
| 2021 July | 35 | 17 | 52 |
| 2021 June | 36 | 27 | 63 |
| 2021 May | 42 | 29 | 71 |
| 2021 April | 92 | 81 | 173 |
| 2021 March | 61 | 18 | 79 |
| 2021 February | 27 | 15 | 42 |
| 2021 January | 25 | 22 | 47 |
| 2020 December | 29 | 14 | 43 |
| 2020 November | 21 | 21 | 42 |
| 2020 October | 16 | 21 | 37 |
| 2020 September | 29 | 20 | 49 |
| 2020 August | 2 | 2 | 4 |
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