Biosimilares – Nuestro futuro próximo
DOI:
https://doi.org/10.29176/2590843X.55Abstract
La crisis del sistema de salud colombiano, con un déficit de más de 5 billones de pesos y deudas crecientes con hospitales, proveedores y personal médico, es un problema preocupante y de muchas maneras puede afectarnos a nosotros y a nuestros pacientes.
Author Biography
Natalia Hernández M., Asociación Colombiana de Dermatología y Cirugia Dermatológica
MD. Dermatólogo
References
Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of cinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(Supl.3):S123-32. https://doi.org/10.1002/jcph.339
World Health Organization. Guidelines on evaluation of similar biotherapeutic products. Geneva: World Health Organization; 2009.
FDA Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. HHS FDA/CDER/CBER, Apr. 2015. Disponible en: https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues, Feb. 2006 Disponble en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf
European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - nonclinical and clinical issues. May 2012. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
Ministerio de Salud y Protección Social. Decreto1782 de 2014. Fecha de consulta: 12 de junio 2018: Disponible en: https://www.minsalud.gov.co/Normatividad.../Decreto%201782%20de%202014.pdf.
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