<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2594-2166</journal-id>
<journal-title><![CDATA[Medicina y ética]]></journal-title>
<abbrev-journal-title><![CDATA[Med. ética]]></abbrev-journal-title>
<issn>2594-2166</issn>
<publisher>
<publisher-name><![CDATA[Universidad Anáhuac México, Facultad de Bioética]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2594-21662023000200481</article-id>
<article-id pub-id-type="doi">10.36105/mye.2023v34n2.05</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Los medicamentos biosimilares como medicamentos esenciales: reflexiones éticas y legales]]></article-title>
<article-title xml:lang="en"><![CDATA[Biosimilar drugs as essential drugs: ethical and legal reflections]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Noguera Peña]]></surname>
<given-names><![CDATA[Alfonso]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castillo Rodríguez]]></surname>
<given-names><![CDATA[Carlos del]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Complutense de Madrid Facultad de Farmacia ]]></institution>
<addr-line><![CDATA[Madrid ]]></addr-line>
<country>Spain</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2023</year>
</pub-date>
<volume>34</volume>
<numero>2</numero>
<fpage>481</fpage>
<lpage>520</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S2594-21662023000200481&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S2594-21662023000200481&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S2594-21662023000200481&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen El presente artículo recapacita sobre las reformas normativas acontecidas en las últimas décadas respecto al uso racional de los medicamentos, y las medidas operadas en torno a la disminución del gasto farmacéutico. En este contexto, debe destacarse el elevado coste de las terapias biológicas y las dificultades de acceso a las mismas -especialmente en los países en vías de desarrollo-. Los medicamentos biosimilares son poseedores de garantías sanitarias análogas -semejantes o equivalentes- a los medicamentos de referencia, pero no están sometidos a una protección por una patente y facilitan la accesibilidad a los pacientes, así como al reparto equitativo de los recursos terapéuticos. Además, algunos de ellos están incluido en la lista de medicamentos esenciales de la Organización Mundial de la Salud (OMS). Asimismo, se examina el papel de los medicamentos biosimilares como esenciales y la posibilidad de mejorar el acceso equitativo a estos recursos sanitarios a través de la prestación farmacéutica.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract This article reflects on the regulatory reforms that have taken place in recent decades with respect to the rational use of drugs, and the measures taken to reduce pharmaceutical expenditure. In this context, the high cost of biological therapies and the difficulties of access to them -especially in developing countries- should be highlighted. Biosimilar drugs have analogous health guarantees -similar or equivalent- to reference drugs but are not subject to patent protection and facilitate accessibility for patients, as well as the equitable distribution of therapeutic resources. In addition, some of them are included in the list of essential drugs of the World Health Organization (WHO). The role of biosimilar drugs as essential drugs and the possibility of improving equitable access to these health resources through pharmaceutical provision are also examined.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[salud pública]]></kwd>
<kwd lng="es"><![CDATA[accesibilidad]]></kwd>
<kwd lng="es"><![CDATA[acceso universal]]></kwd>
<kwd lng="es"><![CDATA[medicamentos genéricos]]></kwd>
<kwd lng="es"><![CDATA[propiedad intelectual]]></kwd>
<kwd lng="en"><![CDATA[public health]]></kwd>
<kwd lng="en"><![CDATA[accessibility]]></kwd>
<kwd lng="en"><![CDATA[universal access]]></kwd>
<kwd lng="en"><![CDATA[generic drugs]]></kwd>
<kwd lng="en"><![CDATA[intellectual property]]></kwd>
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