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A biosimilar has highly similar physical, chemical and biological properties to the reference medicine. Although there may be small differences to the reference medicine, they are not clinically significant from a safety or efficacy perspective. For biosimilars to be approved in the European Union, the same strict standards of quality, safety and efficacy that apply to any other medical product must be met.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Aspects such as interchangeability, a change known as ‘switching’, and the substitution of reference medicines for biosimilars or between biosimilars is still being debated and not yet regulated at the European level; the decision to do so or not is left to each individual state member.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Because the introduction of biosimilar medicines is a cost-effective alternative to using reference medicines, the delay in their incorporation implies a lost opportunity in terms of medicine expenses savings for the public health systems. But this lost opportunity not only refers to the lower price of biosimilar products, but also to the competition placed on the reference medicine by the new competitors. In this regard, unlike generic medicines, the number of pharmaceutical companies able to develop biosimilar medicines that meet EMA standards are minimal, given the technical complexities and the high development cost.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The health administration faces the challenge of promoting their use, defining incentives for hospitals and clinics for their use and establishing indicators and objectives of use.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Despite these obvious benefits, Spain uses far fewer biosimilar medicines in Spain than the other principal economies of European countries, although there has been a gradual increase in their introduction in the recent commercialisation of biosimilar medicines (rituximab and etanercept).<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Some of the reasons for this delay include: a lack of knowledge of the concept of biosimilar medicine; therapeutic inertia; concern about the confusion that surrounds the introduction of different brands and presentations (sometimes with different administration devices) and a possible the nocebo effect.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">And the required additional time and effort that prescribing doctors who switch to biosimilar must make is another obstacle. This could be counteracted by gain sharing, a system where health professionals are rewarded in some way for their efforts to introduce cost savings into the health care system.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The promotion, impulse and sustainability of the use of biosimilar medicines require a variety of strategies.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> Incentives should be designed for prescribers and health institutions that consider the needs of the referring doctors and health professionals who are treating the patient, as well as the objectives of the health centre or institution. To facilitate the switch (change from one reference medicine to a biosimilar product or from one biosimilar product to another) it would be best to first ensure the patient's collaboration, with guides and policies or biosimilar quotas, which would facilitate a fluid change in the care process.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The public purchasing of medicines plays an important role in reducing a potential risk of shortages through the inclusion of different bidders, and ensures the existence of competition between the different holders of commercialisation licenses. Furthermore, decisions to purchase biosimilar medicines must incorporate additional criteria beyond price, and in this way fostering the provision of added value in the care process, for example, in patient services, the design of administration devices and improvements in formulations.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Finally, the regulation of prices and financing of medicines should encourage manufacturers of reference biological medicines and biosimilar medicines to continue innovating, while establishing a price policy that balances the savings objective for health systems and guarantees a market interest in the development and authorisation of long-term biosimilar medicines.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Guiu Segura JM, Gilabert Perramon A. Medicamentos biosimilares: medidas para fomentar su uso. Med Clin (Barc). 2020;154:148.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "European Medicines Agency; European Commission. Guia biosimilares en la UE: Guía informativa para profesionales sanitarios; 2018." ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "IQVIA. The impact of biosimilar competition in Europe. 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Journal Information
Vol. 154. Issue 4.
Pages 148 (February 2020)
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Vol. 154. Issue 4.
Pages 148 (February 2020)
Letter to the Editor
Biosimilar drugs: Measures to promote their use
Medicamentos biosimilares: medidas para fomentar su uso
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Josep Maria Guiu Segura
, Antoni Gilabert Perramon
Corresponding author
Consorci de Salut i Social de Catalunya, Barcelona, Spain
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