<?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>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942021000200131</article-id>
<article-id pub-id-type="doi">10.30827/ars.v62i2.15862</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina]]></article-title>
<article-title xml:lang="en"><![CDATA[Marketing authorization of biologic and biotechnological products in Latin America]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramírez-Telles]]></surname>
<given-names><![CDATA[Mariana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mora-Román]]></surname>
<given-names><![CDATA[Juan José]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fallas-Cartín]]></surname>
<given-names><![CDATA[Milena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Roche Servicios S. A. Área de Asuntos Regulatorios Departamento de Asuntos Médicos]]></institution>
<addr-line><![CDATA[Heredia ]]></addr-line>
<country>Costa Rica</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad de Costa Rica Facultad de Farmacia Departamento de Farmacia Industrial]]></institution>
<addr-line><![CDATA[San José ]]></addr-line>
<country>Costa Rica</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<volume>62</volume>
<numero>2</numero>
<fpage>131</fpage>
<lpage>143</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942021000200131&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942021000200131&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942021000200131&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción:  los medicamentos biológicos se definen como productos cuyos ingredientes activos son producidos por una fuente biológica, mientras que un producto biotecnológico se desarrolla a partir del aislamiento de un gen de interés y su clonación.  Método:  se realizó un estudio comparativo de las regulaciones vigentes a julio de 2020 relacionadas con medicamentos biológicos y biotecnológicos de los países de Centroamérica y el Caribe que actualmente disponen de un marco regulatorio para su registro, con respecto a aquellas de Chile y Brasil.  Resultados:  existen diferencias relevantes en diversos aspectos. Dentro de la información general solicitada se encontraron variaciones para las definiciones de autoridad reguladora de referencia, producto biotecnológico, producto de referencia y producto innovador. También se hallaron divergencias para la información no clínica y clínica solicitada, y los programas de farmacovigilancia. Para productos biosimilares se distinguieron particularidades referentes a su definición y la de ejercicio de biosimilitud, así como para aspectos propios de su utilización como lo son la extrapolación de indicaciones y la sustitución automática o intercambiabilidad. Finalmente, para su etiquetado se requiere mayor estudio por parte de las autoridades sanitarias.  Conclusiones:  una vez realizada la revisión de la normativa respecto al registro sanitario de productos biológicos y biotecnológicos en nueve países de América Latina, se encontró que la información solicitada no se halla homologada.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction:  biological products are defined as products whose active ingredients are produced by a biological source, while biotechnological medicine is developed from the isolation of a gene of interest and its cloning.  Method:  a comparative study was carried out of the regulations in force as of July 2020 related to biological and biotechnological drugs of the countries of Central America and the Caribbean that currently have a regulatory framework for their registration, with respect to those of Chile and Brazil.  Results:  there are relevant differences in various aspects. Within the general information requested, variations were found for the definitions of Stringent Regulatory Authority, biotechnological product, reference product, and innovative product. Also, divergences were found for the non-clinical and clinical information requested and the Pharmacovigilance programs. For biosimilar products, particularities were distinguished regarding their definition and the exercise of biosimilarity, as well as for aspects of their use, such as the extrapolation of indications and automatic substitution or interchangeability. Finally, their labeling requires further study by the health regulatory authorities.  Conclusions:  after reviewing the regulations for the marketing authorization of biological and biotechnological products in nine Latin American countries, it was found that the requested information is not homologated.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[medicamentos biológicos]]></kwd>
<kwd lng="es"><![CDATA[medicamentos biosimilares]]></kwd>
<kwd lng="es"><![CDATA[registro de medicamentos]]></kwd>
<kwd lng="es"><![CDATA[legislación farmacéutica]]></kwd>
<kwd lng="en"><![CDATA[biological products]]></kwd>
<kwd lng="en"><![CDATA[biosimilar pharmaceuticals]]></kwd>
<kwd lng="en"><![CDATA[products registration]]></kwd>
<kwd lng="en"><![CDATA[pharmacy legislation]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[de Mora]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Fauser]]></surname>
<given-names><![CDATA[BCJM]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biosimilar to recombinant human FSH medicines: comparable efficacy and safety to the original biologic]]></article-title>
<source><![CDATA[Reprod BioMed Online]]></source>
<year>2017</year>
<volume>35</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>81-6</page-range></nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Kinch]]></surname>
<given-names><![CDATA[MS]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[An overview of FDA-approved biologics medicines]]></article-title>
<source><![CDATA[Drug Discov Today]]></source>
<year>2015</year>
<volume>20</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>393-8</page-range></nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Knezevic]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Griffiths]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biosimilars - Global issues, national solutions]]></article-title>
<source><![CDATA[Biologicals]]></source>
<year>2011</year>
<volume>39</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>252-5</page-range></nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Patel]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Gillis]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Naggar]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Mistry]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Mantzoros]]></surname>
<given-names><![CDATA[CS]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The rise of biosimilars: How they got here and where they are going]]></article-title>
<source><![CDATA[Metabolism]]></source>
<year>2017</year>
<volume>75</volume>
<page-range>45-53</page-range></nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Avalos]]></surname>
<given-names><![CDATA[BR]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Bring on the Biosimilars!]]></article-title>
<source><![CDATA[Biol Blood Marrow Transplant]]></source>
<year>2015</year>
<volume>21</volume>
<numero>11</numero>
<issue>11</issue>
<page-range>1859-60</page-range></nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schreitmüller]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Barton]]></surname>
<given-names><![CDATA[B]]></given-names>
</name>
<name>
<surname><![CDATA[Zharkov]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Bakalos]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Comparative immunogenicity assessment of biosimilars]]></article-title>
<source><![CDATA[Future Oncol]]></source>
<year>2019</year>
<volume>15</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>319-29</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Kabir]]></surname>
<given-names><![CDATA[ER]]></given-names>
</name>
<name>
<surname><![CDATA[Moreino]]></surname>
<given-names><![CDATA[SS]]></given-names>
</name>
<name>
<surname><![CDATA[Sharif Siam]]></surname>
<given-names><![CDATA[MK]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy]]></article-title>
<source><![CDATA[Biomolecules]]></source>
<year>2019</year>
<volume>9</volume>
<numero>9</numero>
<issue>9</issue>
<page-range>410</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Abas]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Regulatory guidelines for biosimilars in Malaysia]]></article-title>
<source><![CDATA[Biologicals]]></source>
<year>2011</year>
<volume>39</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>339-42</page-range></nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Mendoza-Macedo]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Romero-Díaz]]></surname>
<given-names><![CDATA[AJ]]></given-names>
</name>
<name>
<surname><![CDATA[Miranda-Hernández]]></surname>
<given-names><![CDATA[MP]]></given-names>
</name>
<name>
<surname><![CDATA[Campos García]]></surname>
<given-names><![CDATA[VR]]></given-names>
</name>
<name>
<surname><![CDATA[Ramírez-Ibañez]]></surname>
<given-names><![CDATA[ND]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America]]></article-title>
<collab>Juárez-Bayardo LC et al</collab>
<source><![CDATA[Electron J Biotechnol]]></source>
<year>2016</year>
<volume>24</volume>
<page-range>63-9</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schiestl]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products]]></article-title>
<source><![CDATA[Biologicals]]></source>
<year>2011</year>
<volume>39</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>297-9</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hechavarría Núñez]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Pérez Massipe]]></surname>
<given-names><![CDATA[RO]]></given-names>
</name>
<name>
<surname><![CDATA[Orta Hernández]]></surname>
<given-names><![CDATA[SD]]></given-names>
</name>
<name>
<surname><![CDATA[Martínez Muñoz]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Jacobo Casanueva]]></surname>
<given-names><![CDATA[OL]]></given-names>
</name>
<name>
<surname><![CDATA[Pérez Rodríguez]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The regulatory framework for similar biotherapeutic products in Cuba]]></article-title>
<source><![CDATA[Biologicals]]></source>
<year>2011</year>
<volume>39</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>317-20</page-range></nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<source><![CDATA[Sistema de Evaluación de Autoridades Reguladoras Nacionales de Medicamentos]]></source>
<year>2020</year>
<publisher-loc><![CDATA[Washington D. C. ]]></publisher-loc>
<publisher-name><![CDATA[Organización Panamericana de la Salud]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="book">
<collab>Presidencia de la República</collab>
<source><![CDATA[Reglamento Técnico: RT 440:2010. Reglamento de Inscripción y Control de Medicamentos Biológicos N°37006-S]]></source>
<year>2009</year>
<publisher-loc><![CDATA[San José ]]></publisher-loc>
<publisher-name><![CDATA[Presidencia de la República]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="book">
<collab>Dirección Nacional de Medicamentos de El Salvador</collab>
<source><![CDATA[Guía para el registro de medicamentos biológicos y biotecnológicos]]></source>
<year>2017</year>
<publisher-loc><![CDATA[La Libertad ]]></publisher-loc>
<publisher-name><![CDATA[Gobierno de El Salvador]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="book">
<collab>Dirección de Regulación.Vigilancia y Control de la Salud</collab>
<source><![CDATA[Registro Sanitario de Referencia para Productos Biológicos y Biotecnológicos]]></source>
<year>2019</year>
<publisher-loc><![CDATA[Ciudad de Guatemala ]]></publisher-loc>
<publisher-name><![CDATA[Ministerio de Salud y Asistencia Social]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="book">
<collab>Agencia de Regulación Sanitaria de Honduras</collab>
<source><![CDATA[Comunicado C-003-ARSA-2018]]></source>
<year>2018</year>
<publisher-loc><![CDATA[Tegucigalpa ]]></publisher-loc>
<publisher-name><![CDATA[Gobierno de la República de Honduras]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="book">
<collab>Ministerio de Salud</collab>
<source><![CDATA[Decreto Ejecutivo N°95 (14 de mayo de 2019)]]></source>
<year>2019</year>
<publisher-loc><![CDATA[Ciudad de Panamá ]]></publisher-loc>
<publisher-name><![CDATA[Gobierno de la República de Panamá]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B18">
<label>18</label><nlm-citation citation-type="book">
<collab>Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos</collab>
<source><![CDATA[Requisitos para el Registro Sanitario de Productos Biológicos de Uso Humano]]></source>
<year>2015</year>
<publisher-loc><![CDATA[La Habana ]]></publisher-loc>
<publisher-name><![CDATA[Ministerio de Salud Pública]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B19">
<label>19</label><nlm-citation citation-type="book">
<collab>Ministerio de Salud Pública</collab>
<source><![CDATA[Reglamento Técnico para el Registro Sanitario de Medicamentos Biotecnológicos Innovadores y No Innovadores para Uso Humano en la República Dominicana]]></source>
<year>2016</year>
<publisher-loc><![CDATA[Santo Domingo ]]></publisher-loc>
<publisher-name><![CDATA[Ministerio de Salud Pública]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B20">
<label>20</label><nlm-citation citation-type="book">
<collab>Agencia Nacional de Vigilancia Sanitaria</collab>
<source><![CDATA[RDC 55/2010: dispõe sobre o registro de produtos biológicos novos e produtos biológicos e dá outras providências]]></source>
<year>2010</year>
<publisher-loc><![CDATA[Brasilia ]]></publisher-loc>
<publisher-name><![CDATA[Ministerio da Saude]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B21">
<label>21</label><nlm-citation citation-type="book">
<collab>Subsecretaría de Salud Pública</collab>
<source><![CDATA[Registro sanitario de productos biotecnológicos derivados de técnicas ADN recombinantes]]></source>
<year>2018</year>
<publisher-loc><![CDATA[Santiago ]]></publisher-loc>
<publisher-name><![CDATA[Ministerio de Salud]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B22">
<label>22</label><nlm-citation citation-type="book">
<collab>WHO Expert Committee on Specifications for Pharmaceutical Preparations</collab>
<source><![CDATA[Health hazard evaluation report]]></source>
<year>2018</year>
<publisher-loc><![CDATA[Ginebra ]]></publisher-loc>
<publisher-name><![CDATA[Organización Mundial de la Salud]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B23">
<label>23</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Davidson]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Grace]]></surname>
<given-names><![CDATA[AJ]]></given-names>
</name>
<name>
<surname><![CDATA[Schwarz]]></surname>
<given-names><![CDATA[EW]]></given-names>
</name>
<name>
<surname><![CDATA[Vickers]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The Value of the Certificate of Pharmaceutical Product in Registration of Medicinal Products]]></article-title>
<source><![CDATA[Drug Inf J]]></source>
<year>2002</year>
<volume>36</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>163-7</page-range></nlm-citation>
</ref>
<ref id="B24">
<label>24</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Patel]]></surname>
<given-names><![CDATA[KT]]></given-names>
</name>
<name>
<surname><![CDATA[Chotai]]></surname>
<given-names><![CDATA[NP]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Pharmaceutical GMP: past, present, and future - a review]]></article-title>
<source><![CDATA[Pharmazie]]></source>
<year>2008</year>
<volume>63</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>251-5</page-range></nlm-citation>
</ref>
<ref id="B25">
<label>25</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Thorat]]></surname>
<given-names><![CDATA[SB]]></given-names>
</name>
<name>
<surname><![CDATA[Banarjee]]></surname>
<given-names><![CDATA[SK]]></given-names>
</name>
<name>
<surname><![CDATA[Gaikwad]]></surname>
<given-names><![CDATA[DD]]></given-names>
</name>
<name>
<surname><![CDATA[Jadhav]]></surname>
<given-names><![CDATA[SL]]></given-names>
</name>
<name>
<surname><![CDATA[Thorat]]></surname>
<given-names><![CDATA[RM]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Clinical Trial: A Review]]></article-title>
<source><![CDATA[Int J Pharm Sci Rev Res]]></source>
<year>2010</year>
<volume>1</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>101-6</page-range></nlm-citation>
</ref>
<ref id="B26">
<label>26</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Boehncke]]></surname>
<given-names><![CDATA[WH]]></given-names>
</name>
<name>
<surname><![CDATA[Brembilla]]></surname>
<given-names><![CDATA[NC]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Immunogenicity of biologic therapies: causes and consequences]]></article-title>
<source><![CDATA[Expert Rev Clin Immunol]]></source>
<year>2018</year>
<volume>14</volume>
<numero>6</numero>
<issue>6</issue>
<page-range>513-23</page-range></nlm-citation>
</ref>
<ref id="B27">
<label>27</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Garcês]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Demengeot]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The Immunogenicity of Biologic Therapies]]></article-title>
<source><![CDATA[Curr Probl Dermatol]]></source>
<year>2018</year>
<volume>53</volume>
<page-range>37-48</page-range></nlm-citation>
</ref>
<ref id="B28">
<label>28</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Doevendans]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Schellekens]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Immunogenicity of Innovative and Biosimilar Monoclonal Antibodies]]></article-title>
<source><![CDATA[Antibodies (Basel)]]></source>
<year>2019</year>
<volume>8</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>21</page-range></nlm-citation>
</ref>
<ref id="B29">
<label>29</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Felix T]]></surname>
<given-names><![CDATA[Jordan JB]]></given-names>
</name>
<name>
<surname><![CDATA[Akers]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Patel B]]></surname>
<given-names><![CDATA[Drago D]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Current state of biologic pharmacovigilance in the European Union: improvements are needed]]></article-title>
<source><![CDATA[Expert Opin Drug Saf]]></source>
<year>2019</year>
<volume>18</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>231-40</page-range></nlm-citation>
</ref>
<ref id="B30">
<label>30</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tesser]]></surname>
<given-names><![CDATA[JRP]]></given-names>
</name>
<name>
<surname><![CDATA[Furst]]></surname>
<given-names><![CDATA[DE]]></given-names>
</name>
<name>
<surname><![CDATA[Jacobs]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biosimilars and the extrapolation of indications for inflammatory conditions]]></article-title>
<source><![CDATA[Biologics]]></source>
<year>2017</year>
<page-range>11</page-range></nlm-citation>
</ref>
<ref id="B31">
<label>31</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Curigliano]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[O´Connor]]></surname>
<given-names><![CDATA[DP]]></given-names>
</name>
<name>
<surname><![CDATA[Rosenberg]]></surname>
<given-names><![CDATA[JA]]></given-names>
</name>
<name>
<surname><![CDATA[Jacobs]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biosimilars: Extrapolation for oncology]]></article-title>
<source><![CDATA[Crit Rev Oncol Hematol]]></source>
<year>2016</year>
<volume>104</volume>
<page-range>131-7</page-range></nlm-citation>
</ref>
<ref id="B32">
<label>32</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[de Mora]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Balsa]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Cornide-Santos]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Carrascosa]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Marsal]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biosimilar and interchangeable: Inseparable Scientific concepts?]]></article-title>
<collab>Gisbert JP et al</collab>
<source><![CDATA[Br J Clin Pharmacol]]></source>
<year>2019</year>
<volume>85</volume>
<numero>11</numero>
<issue>11</issue>
<page-range>2460-3</page-range></nlm-citation>
</ref>
<ref id="B33">
<label>33</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ascef]]></surname>
<given-names><![CDATA[BO]]></given-names>
</name>
<name>
<surname><![CDATA[Silva]]></surname>
<given-names><![CDATA[RGLD]]></given-names>
</name>
<name>
<surname><![CDATA[Oliveira Júnior]]></surname>
<given-names><![CDATA[HA]]></given-names>
</name>
<name>
<surname><![CDATA[Soárez]]></surname>
<given-names><![CDATA[PC]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Interchangeability and substitution of biosimilars: is health technology assessment (HTA) a tool for decision-making?]]></article-title>
<source><![CDATA[Cad Saúde Publica]]></source>
<year>2019</year>
<volume>35</volume>
<numero>9</numero>
<issue>9</issue>
</nlm-citation>
</ref>
<ref id="B34">
<label>34</label><nlm-citation citation-type="book">
<collab>Consejo de Ministros de Integración Económica Centroamericana</collab>
<source><![CDATA[RTCA 11.03.59:11 (Productos Farmacéuticos. Medicamentos de Uso Humano. Requisitos de Registro Sanitario)]]></source>
<year>2013</year>
<publisher-loc><![CDATA[Ciudad de Guatemala ]]></publisher-loc>
<publisher-name><![CDATA[Secretaría de Integración Económica Centroamericana]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B35">
<label>35</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Viscusi]]></surname>
<given-names><![CDATA[WK]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Efficacy of Labeling of Foods and Pharmaceuticals]]></article-title>
<source><![CDATA[Annu Rev Public Health]]></source>
<year>1994</year>
<volume>15</volume>
<page-range>325-43</page-range></nlm-citation>
</ref>
<ref id="B36">
<label>36</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Evens]]></surname>
<given-names><![CDATA[RP]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Medical Affairs and Professional Services]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Evens]]></surname>
<given-names><![CDATA[RP]]></given-names>
</name>
</person-group>
<source><![CDATA[Drug and Biological Development: From Molecule to Product and Beyond]]></source>
<year>2007</year>
<publisher-loc><![CDATA[Nueva York ]]></publisher-loc>
<publisher-name><![CDATA[Springer]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
