Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study.

Thorpe, Robin; Grampp, Gustavo; Kang, Hye-Na; Knezevic, Ivana

Thorpe, Robin; Grampp, Gustavo; Kang, Hye-Na; Knezevic, Ivana.

Afiliación

Thorpe R; Welwyn, United Kingdom.
Grampp G; Biotherapeutics Group of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), United Kingdom.
Kang HN; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland. Electronic address: kangh@who.int.
Knezevic I; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland.

Biologicals ; 62: 8-15, 2019 Nov.

Article en En | MEDLINE | ID: mdl-31668854

Asunto(s)

Biosimilares Farmacéuticos/normas; Biosimilares Farmacéuticos/uso terapéutico; Aprobación de Drogas; Eritropoyetina/normas; Eritropoyetina/uso terapéutico; Humanos; Control de Calidad

Palabras clave

Biosimilar; Case study; Erythropoietin; Regulatory evaluation; Similar biotherapeutic product; WHO

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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Eritropoyetina / Aprobación de Drogas / Biosimilares Farmacéuticos Tipo de estudio: Guideline / Prognostic_studies / Qualitative_research / Risk_factors_studies Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Reino Unido

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