Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph.

Afiliação

Cilia M; Medicines Authority, Sir Temi Zammit Buildings, Malta Life Sciences Park, San Gwann, SGN 3000, Malta.
Ruiz S; Agencia Española de Medicamentos y Productos Sanitarios, Parque Empresarial Las Mercedes, Edificio 8, C/Campezo 1, 28022, Madrid, Spain.
Richardson P; European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
Salmonson T; European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
Serracino-Inglott A; European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
Wirth F; Läkemedelsverket, Dag Hammarskjölds väg 42, 75237, Uppsala, Sweden.
Borg JJ; Medicines Authority, Sir Temi Zammit Buildings, Malta Life Sciences Park, San Gwann, SGN 3000, Malta.

AAPS PharmSciTech ; 19(2): 489-511, 2018 Feb.

Article em En | MEDLINE | ID: mdl-29027130

Assuntos

Medicamentos Biossimilares/normas; União Europeia; Marketing

Palavras-chave

biosimilars; chemistry manufacturing control; deficiencies; marketing authorisations; pharmaceutical development

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares Tipo de estudo: Prognostic_studies Idioma: En Revista: AAPS PharmSciTech Assunto da revista: FARMACOLOGIA Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Malta

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