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.

Afiliação

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 em En | MEDLINE | ID: mdl-31668854

Assuntos

Medicamentos Biossimilares/normas; Medicamentos Biossimilares/uso terapêutico; Aprovação de Drogas; Eritropoetina/normas; Eritropoetina/uso terapêutico; Humanos; Controle de Qualidade

Palavras-chave

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

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Eritropoetina / Aprovação de Drogas / Medicamentos Biossimilares Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research / Risk_factors_studies Limite: Humans Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Reino Unido

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