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La Agencia Europea de Medicamentos acepta al SB4, el candidato de Samsung Bioepis a biosimilar del Enbrel®, para un examen regulatorio
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-- Primer biosimilar de Samsung Bioepis que llega a la AEM para un examen regulatorio --

-- Primer biosimilar de Enbrel que se presenta en la UE --

-- Si se autoriza, el SB4 será comercializado en Europa por Biogen Idec --


News provided by

Samsung Bioepis

Jan 21, 2015, 10:44 ET

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INCHEON, Corea del Sur, 21 de enero de 2015 /PRNewswire/ -- En el día de hoy, Samsung Bioepis Co., Ltd. anunció que la Solicitud de autorización para comercialización (MAA, por sus siglas en inglés) del SB4, su candidato a biosimilar del Enbrel (etanecerpt), ha sido validada y aceptada para un examen por parte de la Agencia Europea de Medicamentos (AEM). La aceptación de la MAA marca al primer biosimilar del Enbrel que llega hasta el examen regulatorio de la Unión Europea (UE). La MAA se basa en los resultados de un ensayo clínico de Fase III en pacientes con artritis reumatoide (RA, por sus siglas en inglés) moderada a severa.

En Europa, el Enbrel está indicado para el tratamiento de una variedad de enfermedades reumáticas, incluyendo la RA moderada a severa, ciertas formas de artritis idiopática juvenil, artritis psoriásica, espondilitis anquilosante y psoriasis en placa. Si la AEM lo autoriza, el SB4 podría estar disponible para tratar todas las enfermedades para las que se indica al Enbrel.

"Esta validación de la MAA representa un hito significativo para Samsung Bioepis en su labor en pos de desarrollar y fabricar biosimilares de clase mundial. Y lo que es más importante, ofrece una oportunidad para proporcionar terapias de excelente calidad y efectividad con el propósito de ampliar el acceso a los pacientes de Europa", afirmó Christopher Hansung Ko, Director Ejecutivo de Samsung Bioepis.

Si se autoriza por parte de la AEM, el SB4 será comercializado en Europa por Biogen Idec. También será producido en la planta de fabricación de la compañía en Hillerød, Dinamarca, la cual es una de las mayores plantas de fabricación de biológicos en el ámbito mundial.

Además de su presentación en Europa, Samsung Bioepis tiene intención de seguir adelante con la presentación de solicitudes para obtener aprobaciones regulatorias en otras partes del mundo.

Acerca del SB4

Samsung Bioepis condujo previamente estudios clínicos del SB4 en Fase I y Fase III. La MAA para el biosimilar del etanecerpt se basó en datos de un estudio multicentro, aleatorio, controlado y de Fase III realizado en Europa, donde el SB4 demostró su equivalencia con el Enbrel®. Se evaluaron los criterios de valoración primarios y secundarios del estudio y cumplieron con el estándar de calificación para el envío de la MAA. Los datos completos del estudio estarán disponibles más adelante este año.

Acerca de Samsung Bioepis

La compañía fue establecida en 2012 como parte del grupo Samsung, con la misión de producir productos biofarmacéuticos de excelente calidad y asequibles para muchos pacientes necesitados. La compañía apunta a ser la empresa biofarmacéutica líder en el ámbito mundial, con su patrimonio de innovación y tecnologías de avanzada. Si desea más información, ingrese a www.samsungbioepis.com.

FUENTE Samsung Bioepis

Related Links

http://www.samsungbioepis.com

SOURCE Samsung Bioepis

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