Special Article
Biosimilar Drugs in Mexico: Position of the Mexican College of Rheumatology, 2012
Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012
Rolando Espinosa Moralesa,
, Alejandro Díaz Borjónb, Leonor Adriana Barile Fabrisc, Jorge Antonio Esquivel Valeriod, Gabriel Medrano Ramíreze, César Alejandro Arce Salinasf, Eduardo Rubén Barreira Mercadog, Mario Humberto Cardiel Ríosh, Efraín Díaz Jouaneni, Francisco Javier Flores Murrietaj, Antonio Fraga Mouretk, Mario Alberto Garza Elizondol, Miguel Luján Estradam, Francisco José Muñoz Barradasn, Juan Osvaldo Talavera Piñao, Olga Lidia Vera Lastrap
Corresponding author
a Instituto Nacional de Rehabilitación, Secretaría de Salud, Ciudad de México, Mexico
b Hospital Ángeles Lomas, Huixquilucan, Edo. de Méx., Mexico
c Hospital de Especialidades «Bernardo Sepúlveda», Centro Médico Nacional Siglo XXI, IMSS, Ciudad de México, Mexico
d Hospital Universitario «José Eleuterio González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico
e Hospital General de México, O. D., Presidente del Consejo Mexicano de Reumatología, A.C., Ciudad de México, Mexico
f Hospital Central Sur de Alta Especialidad de PEMEX, Ciudad de México, Mexico
g Universidad Autónoma de Querétaro, Universidad del Valle de México, Campus Querétaro, Querétaro, Mexico
h Unidad de Investigación «Dr. Mario Alvizouri Muñoz», Hospital General «Dr. Miguel Silva» SSA, Morelia, Michoacán, Mexico
i División de Medicina, Hospital Ángeles Lomas, Huixquilucan, Edo. de Méx., Mexico
j Unidad de Farmacología, Instituto Nacional de Enfermedades Respiratorias (INER), Ciudad de México, Mexico
k Educación e Investigación, Secretaría de Salud del Gobierno del Distrito Federal, Ciudad de México, Mexico
l Departamento de Reumatología, Hospital Universitario «José Eleuterio González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico
m Centro de estudios de Bioequivalencia, Ciudad de México, Mexico
n Fundación Mexicana para Enfermos Reumáticos, A.C. (FUMERAC), Ciudad de México, Mexico
o Unidad de Investigación Médica en Epidemiología Clínica, Centro Médico Nacional Siglo XXI, IMSS, Ciudad de México, Mexico
p Servicio de Medicina Interna, Hospital de Especialidades «Dr. Antonio Fraga Mouret», Centro Médico Nacional La Raza, IMSS, Ciudad de México, Mexico
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(FUMERAC), Ciudad de México, Mexico" "etiqueta" => "<span class="elsevierStyleSup">n</span>" "identificador" => "aff0070" ] 14 => array:3 [ "entidad" => "Unidad de Investigación Médica en Epidemiología Clínica, Centro Médico Nacional Siglo XXI, IMSS, Ciudad de México, Mexico" "etiqueta" => "<span class="elsevierStyleSup">o</span>" "identificador" => "aff0075" ] 15 => array:3 [ "entidad" => "Servicio de Medicina Interna, Hospital de Especialidades «Dr. Antonio Fraga Mouret», Centro Médico Nacional La Raza, IMSS, Ciudad de México, Mexico" "etiqueta" => "<span class="elsevierStyleSup">p</span>" "identificador" => "aff0080" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">With the expiration of patents on biotech drugs, the development of structurally similar substances with the therapeutic qualities of original molecules, in Mexico called biosimilar drugs (BSD) has started. Their presence can promote greater access for users based on their cost, but their use has not been without debate.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Unlike conventional medicines, also called “small molecules”, the biotechnology-derived drugs are complex molecules, so much so that there is no possibility of “absolute equivalence” between “original” and BSD. In this situation, the risks they face in the absence of a clear statement on the rules of conduct and practice among the synthesis and use of BSD are imminent. The <span class="elsevierStyleItalic">European Drug Agency</span> (EMA) and the <span class="elsevierStyleItalic">Food and Drug Administration</span> (FDA) have set the standard in the field; in Mexico, the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) has initiated the necessary regulations for good clinical practice. The issue has also occupied various medical associations and specific groups of stakeholders around the world.</p><p id="par0015" class="elsevierStylePara elsevierViewall">This paper discusses the <span class="elsevierStyleItalic">position of</span> the <span class="elsevierStyleItalic">Mexican College of Rheumatology</span> regarding BSD in this country. We expose the result of a profound reflection by various opinion leaders dealing with the use, research and regulation of biotech drugs.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Context</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Biosimilar Drugs</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Definitions</span><p id="par0020" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1.</span><p id="par0025" class="elsevierStylePara elsevierViewall">Biotech drug: substance produced through biotechnology with molecular effects either for prevention, treatment or rehabilitation of a disease, and presented in a pharmaceutic form. Identified as such given its pharmacological activity and physical, chemical and biological properties.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2.</span><p id="par0030" class="elsevierStylePara elsevierViewall">Innovative biotech drug: this refers to drugs developed originally against a molecular target and has demonstrated efficacy and safety for clinical use.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3.</span><p id="par0035" class="elsevierStylePara elsevierViewall">Biotechnology biosimilar: not an innovative biotech drug, which proves to be biosimilar in terms of safety, quality and efficacy with the reference biotech drug.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">4.</span><p id="par0040" class="elsevierStylePara elsevierViewall">Biotechnology reference: innovative biotech drug that is used as a reference for biotech drug registration.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">5.</span><p id="par0045" class="elsevierStylePara elsevierViewall">The BSD is developed after the end of the patent of the originally approved biological drug (biological reference drug) and has a similar activity.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">6.</span><p id="par0050" class="elsevierStylePara elsevierViewall">Biosimilarity tests: tests, assays and analysis which are required to demonstrate that a biosimilar biotech drug has the same quality, safety and efficacy as the biotech drug of reference.</p></li></ul></p></span></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Worldwide Experience With Non-rheumatic Biosimilar Drugs: An Overview</span><p id="par0055" class="elsevierStylePara elsevierViewall">Since 2004, interferon alfa, recombinant insulin and growth hormone lost their worldwide patent, so it became necessary to regulate all emerging biotech. Regulatory agencies such as EMA and the FDA, and the World Health Organization have begun developing guidelines to regulate these drugs; among the elements that stand out are: physicochemical characterization, clinical efficacy, safety, immunogenicity, and pharmacovigilance.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Regarding clinical use, BSD are not interchangeable, at least in the European Union, and their clinical action cannot be extrapolated from those produced by innovative medicines.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Only in the European Union, from 2006 to 2010 14 BSD were registered and approved.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Regulatory Framework for Biocomparables in Mexico</span><p id="par0065" class="elsevierStylePara elsevierViewall">Different laws and regulations have been established:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">1.</span><p id="par0070" class="elsevierStylePara elsevierViewall">Health Law: Article 222 (7 May 1997).</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">2.</span><p id="par0075" class="elsevierStylePara elsevierViewall">Regulation of Health Products: Articles 87 and 167 (4 February 1998).</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">3.</span><p id="par0080" class="elsevierStylePara elsevierViewall">Addendum to the General Health Law: Article 222 Bis (June 11, 2009).</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">4.</span><p id="par0085" class="elsevierStylePara elsevierViewall">Reform to the General Health Law (general framework for biotech and biosimilar drugs, October 19, 2011).</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">5.</span><p id="par0090" class="elsevierStylePara elsevierViewall">Regulation of new molecules (February 2012).</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">6.</span><p id="par0095" class="elsevierStylePara elsevierViewall">Emergency Standard NOM-EM-001-SSA1-2012.</p></li></ul></p><p id="par0100" class="elsevierStylePara elsevierViewall">It is noteworthy that, on the basis of the latest Mexican legislation, the regulatory authority has not given any recognition to innovative biotech drugs (see <a class="elsevierStyleCrossRef" href="#sec0070">Annex 1</a>).</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Biosimilar Drugs Through Evidence-based Medicine: Fundamentals, Classification and Practice</span><p id="par0105" class="elsevierStylePara elsevierViewall">Evidence-based medicine is a strategy used by physicians to make the best decisions and must be based on three pillars: the best available information in the international literature, physician's experience and the opinions and preferences of the patient.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0110" class="elsevierStylePara elsevierViewall">As part of this strategy, it has been suggested that classifying the data analysis according to the quality of the studies from which it derives and thereafter generate a recommendation is a good strategy. This is particularly relevant when implementing medical treatment. Highest rating should be assigned to the comparative trials with randomization, while those with a lesser score are case series and expert opinions.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0115" class="elsevierStylePara elsevierViewall">In Mexico, only one drug with registration is marketed, for veterinary use, Kikuzubam<span class="elsevierStyleSup">®</span> (rituximab; Probiomed), as an innovative biotech drug and strictly not considered a BSD. We reviewed the world literature through <span class="elsevierStyleItalic">PubMed</span> and <span class="elsevierStyleItalic">EMBASE</span> search engines, there are no published phase <span class="elsevierStyleSmallCaps">III</span> clinical studies with this BSD, and it was based on the comparison of data on efficacy and safety of MabThera<span class="elsevierStyleSup">®</span> (rituximab, Roche) that it obtained its approval. In the only study available, mentioned in the prescribing information in its large and small versions, an open-label, randomized, crossover trial involving 54 patients with NHL is mentioned. It showed that there were no differences between the treatments studied. However, there is no clear assessment of adverse effects nor does it specify the reasons for the losses or deaths in each group, there is no clear evidence on the effectiveness and safety of this drug and it is questionable whether it can be used in other diseases.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> With the information available it is not possible to issue a recommendation based on the evidence about the biotech drug Kikuzubam<span class="elsevierStyleSup">®</span> and the claim made by the manufacturer on interchangeability is incorrect.</p><p id="par0120" class="elsevierStylePara elsevierViewall">Other BSD employed in Latin America (Etanar<span class="elsevierStyleSup">®</span> and Reditux<span class="elsevierStyleSup">®</span>) only have abstracts presented at rheumatology congresses based on observational studies and funded by the manufacturer, without comparison with other treatments.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Posture of the Mexican College of Rheumatology</span><p id="par0125" class="elsevierStylePara elsevierViewall">Therapeutic advances in rheumatology include biotechnological drugs produced from living cells and that may include monoclonal antibodies, soluble receptors and receptor antagonists, which modify various functions.</p><p id="par0130" class="elsevierStylePara elsevierViewall">The increased use of these drugs has caused health expenditures to increase significantly. The expiration of several patents for biotech drugs has led to the production of new options that force both doctors and the government, through its regulatory agencies, to seek legal elements that ensure the quality, efficacy and safety, and accessibility of these drugs.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">Mexico was the first country in Latin America to have a regulatory standard on BSD (2006) that led to the publication in 2009 of a decree that is added to Article 222 Bis of the General Law of Health.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">Under existing Mexican law, the Mexican College of Rheumatology expresses its position on the BSD:<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">1.</span><p id="par0145" class="elsevierStylePara elsevierViewall">It must also be understood that an innovative biotech drug is one that has been developed and registered worldwide for the first time for one or more indications. A BSD is one which through molecular biology techniques achieves a comparable structure and function, similar to the innovative product.</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">2.</span><p id="par0150" class="elsevierStylePara elsevierViewall">The obtention of biotechnology products requires a complex process that does not guarantee that BSD are equal to innovative products. Therefore, BSD efficacy cannot be extrapolated or its safety <span class="elsevierStyleItalic">be considered interchangeable</span>.</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">3.</span><p id="par0155" class="elsevierStylePara elsevierViewall">The safety information for long-term monitoring cannot be adequately assessed if patients change an innovative drug for a BSD or <span class="elsevierStyleItalic">vice versa</span>. The substitution of the drug cannot be an accepted practice.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">4.</span><p id="par0160" class="elsevierStylePara elsevierViewall">Approval of a BSD must meet the preclinical and clinical trials identified by Mexican law (Regulation on New Molecules Committee).<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> We recommend the inclusion of Mexican clinicians with expertise in the field to interact with the new molecules Subcommittee of COFEPRIS (<a href="http://www.cofepris.gob.mx/">www.cofepris.gob.mx</a>), to establish the respective report.</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">5.</span><p id="par0165" class="elsevierStylePara elsevierViewall">The label of each product should clearly emphasize that this is an innovative biotechnological (MB) or biosimilar (BSD) drug.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">6.</span><p id="par0170" class="elsevierStylePara elsevierViewall">The biotech drug maker is obliged to exercise pharmacovigilance for long term side effects and these should be reported to COFEPRIS (<a href="http://www.cofepris.gob.mx/">www.cofepris.gob.mx</a>). We recommend a greater commitment to this responsibility by all health professionals involved with BSD use.</p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">7.</span><p id="par0175" class="elsevierStylePara elsevierViewall">The appropriate use of biotech drugs requires the interaction of physicians, pharmacologists and regulatory entities. This can benefit the right to health of patients as long as they count on quality products, effective and safe.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">8.</span><p id="par0180" class="elsevierStylePara elsevierViewall">This position should be updated in light of new evidence, at least every two years.</p></li></ul></p><p id="par0185" class="elsevierStylePara elsevierViewall">Finally, we show that this working group is in favor of BSD and biotech drug development, both in Mexico and in other parts of the world and their approval by regulatory agencies, provided they are subject to the highest standards of quality in terms of production and development, the evaluation of efficacy and safety with adequate phases <span class="elsevierStyleSmallCaps">III</span> and <span class="elsevierStyleSmallCaps">IV,</span> studies followed by a strict pharmacovigilance program. The goal for the development of BSD must include substantial savings for public health institutions, patients who can afford these medicines with pocket payments and improve access for the wider population to these drugs; however, ensuring maximum therapeutic efficacy and optimal patient safety should take precedence.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Ethical Responsibilities</span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Protection of People and Animals</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors state that no experiments were performed on humans or animals.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Data Confidentiality</span><p id="par0195" class="elsevierStylePara elsevierViewall">The authors state that no patient data appear in this article.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Right to Privacy and Informed Consent</span><p id="par0200" class="elsevierStylePara elsevierViewall">The authors state that no patient data appear in this article.</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle">Conflict of Interest</span><p id="par0205" class="elsevierStylePara elsevierViewall">The Mexican College of Rheumatology received an unrestricted educational support from Roche, Abbott, Pfizer and Janssen.</p><p id="par0210" class="elsevierStylePara elsevierViewall">The authors declare their participation in various projects funded by pharmaceutical companies, all of which have received less than U.S. $ 10,000 (or its equivalent in Mexican pesos).</p><p id="par0215" class="elsevierStylePara elsevierViewall">Barile-Fabris, Eleanor A.: Abbott, Roche, MSD, Janssen, Pfizer, GSK.</p><p id="par0220" class="elsevierStylePara elsevierViewall">Cardiel, Mario H.: Roche, Pfizer, Bristol-Myers Squibb, Amgen, Lilly, Abbott, MSD.</p><p id="par0225" class="elsevierStylePara elsevierViewall">Espinosa, Rolando: Lilly, Sanofi. He is currently president of the Mexican College of Rheumatology, and is closely related to laboratories that produce drugs with therapeutic applications in rheumatology. He does not receive financial compensation for this honorary position.</p><p id="par0230" class="elsevierStylePara elsevierViewall">Valerio Esquivel, Jorge A.: Merck, Sanofi, Roche, Novartis, Aventis, Merck, Schering Plough, Bristol, Abbott, Centocor.</p><p id="par0235" class="elsevierStylePara elsevierViewall">Barreira-Mercado, Eduardo: MSD, Roche, Novartis, Sanofi.</p><p id="par0240" class="elsevierStylePara elsevierViewall">Medrano Ramirez, Gabriel: MSD, Roche, Bristol, Abbott, Janssen, Amgen, Genentech, Anthera.</p><p id="par0245" class="elsevierStylePara elsevierViewall">The remaining authors have declared no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:14 [ 0 => array:2 [ "identificador" => "xres90908" "titulo" => "Abstract" ] 1 => array:2 [ "identificador" => "xpalclavsec78133" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xres90909" "titulo" => "Resumen" ] 3 => array:2 [ "identificador" => "xpalclavsec78132" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Context" "secciones" => array:1 [ 0 => array:3 [ "identificador" => "sec0015" "titulo" => "Biosimilar Drugs" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Definitions" ] ] ] ] ] 6 => array:2 [ "identificador" => "sec0025" "titulo" => "Worldwide Experience With Non-rheumatic Biosimilar Drugs: An Overview" ] 7 => array:2 [ "identificador" => "sec0030" "titulo" => "Regulatory Framework for Biocomparables in Mexico" ] 8 => array:2 [ "identificador" => "sec0035" "titulo" => "Biosimilar Drugs Through Evidence-based Medicine: Fundamentals, Classification and Practice" ] 9 => array:2 [ "identificador" => "sec0040" "titulo" => "Posture of the Mexican College of Rheumatology" ] 10 => array:3 [ "identificador" => "sec0045" "titulo" => "Ethical Responsibilities" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0050" "titulo" => "Protection of People and Animals" ] 1 => array:2 [ "identificador" => "sec0055" "titulo" => "Data Confidentiality" ] 2 => array:2 [ "identificador" => "sec0060" "titulo" => "Right to Privacy and Informed Consent" ] ] ] 11 => array:2 [ "identificador" => "sec0065" "titulo" => "Conflict of Interest" ] 12 => array:2 [ "identificador" => "xack34610" "titulo" => "Acknowledgments" ] 13 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2012-08-15" "fechaAceptado" => "2012-11-21" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec78133" "palabras" => array:6 [ 0 => "Biosimilar" 1 => "Biocomparable" 2 => "Rheumatoid arthritis" 3 => "Biologic" 4 => "Biotechnological" 5 => "Innovator drugs" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec78132" "palabras" => array:6 [ 0 => "Biosimilar" 1 => "Biocomparable" 2 => "Artritis Reumatoide" 3 => "Biológicos" 4 => "Biotecnológicos" 5 => "Fármacos innovadores" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases; however, their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence-based medicine. The Mexican General Health Law contemplates the registration of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Los medicamentos biotecnológicos (MBT) son moléculas complejas cuyo proceso de elaboración impide replicar con gran exactitud la substancia original, por lo que no existe una equivalencia absoluta entre la droga original (innovador) y el biocomparable. Los MBT han probado su eficacia en diversas patologías reumáticas, aunque su alto costo impide su utilización en muchos pacientes. Diversas patentes de medicamentos biotecnológicos han expirado o expiraran próximamente, detonando así el desarrollo de fármacos estructuralmente similares y probablemente con eficacia y seguridad comparable a los medicamentos innovadores, aunque estas características deben ser probadas. La Ley General de Salud Mexicana actual contempla el registro de estos medicamentos para su utilización en nuestro país. Este documento, es una reflexión de miembros del Colegio Mexicano de Reumatología, farmacólogos e investigadores en epidemiología, en conjunción con nuestras autoridades sanitarias, sobre los estudios científicos necesarios de los biocomparables previos y posterior a su incursión en el mercado mexicano.</p>" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0255" class="elsevierStylePara elsevierViewall">Unlike small molecules, biosimilarity tests should assess the quality, consistency, manufacturing process, safety and efficacy, including tests to determine the structure and physicochemical, biological and immunological properties of the molecule.</p> <p id="par0260" class="elsevierStylePara elsevierViewall">The preclinical study protocol comprises:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">1.</span><p id="par0265" class="elsevierStylePara elsevierViewall">Studies of <span class="elsevierStyleItalic">in vitro</span> pharmacodynamics.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">2.</span><p id="par0270" class="elsevierStylePara elsevierViewall">Comparative studies of pharmacodynamics <span class="elsevierStyleItalic">in vivo</span> in relevant animal models if there is a relevant species.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">3.</span><p id="par0275" class="elsevierStylePara elsevierViewall">Comparative preclinical toxicity studies in relevant species.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">4.</span><p id="par0280" class="elsevierStylePara elsevierViewall">Comparison and immunogenicity toxicokinetics in animal.</p></li><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">5.</span><p id="par0285" class="elsevierStylePara elsevierViewall">Local tolerance, if applicable.</p></li></ul></p> <p id="par0290" class="elsevierStylePara elsevierViewall">The Mexican Official Standard establishes the performance of Phase <span class="elsevierStyleSmallCaps">I</span> studies (single-dose clinical safety growing), phase <span class="elsevierStyleSmallCaps">II</span> studies (clinical safety of pharmacokinetics/pharmacodynamics) and phase <span class="elsevierStyleSmallCaps">III</span> studies (clinical therapeutic efficacy and safety); in all these case studies should be comparative to the reference product.</p>" "etiqueta" => "Annex 1" "titulo" => "The Relevance of Bioequivalence Studies Based on Biosimilar Drugs" "identificador" => "sec0070" ] ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Reglamento de insumos para la salud, artículo 222 Bis de la Ley General de Salud 2009." ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Biosimilars of biological drugs therapies, regulatory, clinical and commercial considerations" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "G. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 6 | 13 | 19 |
| 2024 October | 33 | 29 | 62 |
| 2024 September | 43 | 18 | 61 |
| 2024 August | 46 | 42 | 88 |
| 2024 July | 40 | 34 | 74 |
| 2024 June | 61 | 35 | 96 |
| 2024 May | 57 | 27 | 84 |
| 2024 April | 55 | 44 | 99 |
| 2024 March | 51 | 44 | 95 |
| 2024 February | 42 | 41 | 83 |
| 2024 January | 52 | 29 | 81 |
| 2023 December | 36 | 36 | 72 |
| 2023 November | 35 | 23 | 58 |
| 2023 October | 64 | 27 | 91 |
| 2023 September | 62 | 33 | 95 |
| 2023 August | 39 | 14 | 53 |
| 2023 July | 20 | 30 | 50 |
| 2023 June | 26 | 23 | 49 |
| 2023 May | 21 | 9 | 30 |
| 2023 April | 9 | 11 | 20 |
| 2023 March | 57 | 23 | 80 |
| 2023 February | 46 | 27 | 73 |
| 2023 January | 18 | 22 | 40 |
| 2022 December | 70 | 30 | 100 |
| 2022 November | 64 | 29 | 93 |
| 2022 October | 43 | 34 | 77 |
| 2022 September | 30 | 29 | 59 |
| 2022 August | 28 | 41 | 69 |
| 2022 July | 29 | 45 | 74 |
| 2022 June | 39 | 40 | 79 |
| 2022 May | 42 | 44 | 86 |
| 2022 April | 52 | 54 | 106 |
| 2022 March | 51 | 50 | 101 |
| 2022 February | 34 | 27 | 61 |
| 2022 January | 38 | 40 | 78 |
| 2021 December | 29 | 48 | 77 |
| 2021 November | 34 | 52 | 86 |
| 2021 October | 58 | 57 | 115 |
| 2021 September | 42 | 54 | 96 |
| 2021 August | 32 | 42 | 74 |
| 2021 July | 33 | 33 | 66 |
| 2021 June | 33 | 30 | 63 |
| 2021 May | 56 | 38 | 94 |
| 2021 April | 69 | 61 | 130 |
| 2021 March | 44 | 18 | 62 |
| 2021 February | 55 | 25 | 80 |
| 2021 January | 34 | 20 | 54 |
| 2020 December | 36 | 21 | 57 |
| 2020 November | 30 | 32 | 62 |
| 2020 October | 19 | 20 | 39 |
| 2020 September | 36 | 19 | 55 |
| 2020 August | 26 | 19 | 45 |
| 2020 July | 17 | 18 | 35 |
| 2020 June | 30 | 22 | 52 |
| 2020 May | 27 | 18 | 45 |
| 2020 April | 42 | 16 | 58 |
| 2020 March | 20 | 13 | 33 |
| 2020 February | 1 | 0 | 1 |
| 2019 January | 1 | 0 | 1 |
| 2018 May | 3 | 0 | 3 |
| 2018 April | 47 | 7 | 54 |
| 2018 March | 67 | 9 | 76 |
| 2018 February | 41 | 5 | 46 |
| 2018 January | 29 | 9 | 38 |
| 2017 December | 69 | 13 | 82 |
| 2017 November | 62 | 11 | 73 |
| 2017 October | 51 | 11 | 62 |
| 2017 September | 67 | 8 | 75 |
| 2017 August | 72 | 10 | 82 |
| 2017 July | 69 | 12 | 81 |
| 2017 June | 84 | 31 | 115 |
| 2017 May | 83 | 14 | 97 |
| 2017 April | 72 | 18 | 90 |
| 2017 March | 64 | 44 | 108 |
| 2017 February | 62 | 16 | 78 |
| 2017 January | 62 | 13 | 75 |
| 2016 December | 95 | 27 | 122 |
| 2016 November | 113 | 12 | 125 |
| 2016 October | 135 | 19 | 154 |
| 2016 September | 112 | 12 | 124 |
| 2016 August | 92 | 15 | 107 |
| 2016 July | 65 | 11 | 76 |
| 2016 May | 1 | 0 | 1 |
| 2016 February | 1 | 0 | 1 |
| 2016 January | 3 | 11 | 14 |
| 2015 December | 3 | 0 | 3 |
| 2015 November | 1 | 0 | 1 |
| 2015 October | 1 | 14 | 15 |
| 2015 September | 1 | 0 | 1 |
| 2015 August | 1 | 14 | 15 |
| 2015 July | 57 | 8 | 65 |
| 2015 June | 109 | 14 | 123 |
| 2015 May | 135 | 25 | 160 |
| 2015 April | 94 | 11 | 105 |
| 2015 March | 118 | 13 | 131 |
| 2015 February | 104 | 15 | 119 |
| 2015 January | 107 | 18 | 125 |
| 2014 December | 114 | 14 | 128 |
| 2014 November | 117 | 18 | 135 |
| 2014 October | 124 | 19 | 143 |
| 2014 September | 96 | 12 | 108 |
| 2014 August | 88 | 20 | 108 |
| 2014 July | 100 | 18 | 118 |
| 2014 June | 74 | 16 | 90 |
| 2014 May | 70 | 26 | 96 |
| 2014 April | 86 | 22 | 108 |
| 2014 March | 75 | 32 | 107 |
| 2014 February | 78 | 23 | 101 |
| 2014 January | 75 | 27 | 102 |
| 2013 December | 46 | 19 | 65 |
| 2013 November | 54 | 27 | 81 |
| 2013 October | 78 | 17 | 95 |
| 2013 September | 69 | 22 | 91 |
| 2013 August | 107 | 25 | 132 |
| 2013 July | 76 | 20 | 96 |
| 2013 June | 89 | 29 | 118 |
| 2013 May | 112 | 49 | 161 |
| 2013 April | 33 | 21 | 54 |
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