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Coherus anuncia que CHS-0214 (biosimilar etanercept propuesto) supera punto final primario en decisivo estudio clínico farmacocinético
Date:10/28/2013

REDWOOD CITY, California, 28 de octubre de 2013 /PRNewswire/ -- Coherus Biosciences, Inc. anunció hoy que su molécula biosimilar etanercept propuesta, CHS-0214 -un medicamento en investigación- superó el punto final primario de similaridad farmacocinética (PK) clínica con Enbrel® en un estudio clínico de confirmación realizado en sujetos sanos y en conformidad con los requisitos regulatorios de EE. UU., la UE y Japón para similaridad PK. 

Hace poco, Coherus dio a conocer un acuerdo con Baxter International, Inc. para desarrollar y comercializar un biosimilar de la molécula etanercept para Europa, Canadá, Brasil y otros mercados.  La compañía tiene una colaboración en desarrollo con Daiichi Sankyo en Japón.

El estudio transversal de dos períodos cumplió con los criterios para aceptación de similaridad PK clínica en los tres puntos finales obligatorios: concentración de serum máxima (Cmax), área bajo la curva de tiempo-concentración desde el primer hasta el último punto de tiempo medido (AUC0-t), y área bajo la curva tiempo-concentración desde el primer punto de tiempo hasta el infinito (AUC0-inf).  Las medias proporcionales geométricas fueron del 98 % de CHS-0214 para Enbrel® y se enmarcaron plenamente en los límites regulatorios preespecificados para el intervalo de confianza del 90% para Cmax, AUC0-t, y AUC0-inf.

"Este estudio PK clínico confirmatorio es uno de los dos estudios clínicos requeridos para presentar una solicitud de marketing para similar en la mayoría de las jurisdicciones regulatorias.  Nos complace tener resultados tan contundentes y en el futuro muy cercano planeamos comenzar el segundo e
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SOURCE Coherus BioSciences
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