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FDA's Approval of the First Biosimilar to Bevacizumab.
Casak, Sandra J; Lemery, Steven J; Chung, Jee; Fuchs, Chana; Schrieber, Sarah J; Chow, Edwin C Y; Yuan, Weishi; Rodriguez, Lisa; Gwise, Thomas; Rowzee, Anne; Lim, Sue; Keegan, Patricia; McKee, Amy E; Pazdur, Richard.
Afiliação
  • Casak SJ; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Sandra.casak@fda.hhs.gov.
  • Lemery SJ; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chung J; Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fuchs C; Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Schrieber SJ; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chow ECY; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yuan W; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rodriguez L; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gwise T; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rowzee A; Therapeutic Biologics and Biosimilar Staff, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lim S; Therapeutic Biologics and Biosimilar Staff, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Keegan P; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • McKee AE; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 24(18): 4365-4370, 2018 09 15.
Article em En | MEDLINE | ID: mdl-29743182
ABSTRACT
Passage of the Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products. The FDA approved ABP215 (MVASI, bevacizumab-awwb; Amgen) as a biosimilar to U.S.-licensed Avastin (bevacizumab; Genentech) based on an extensive comparative analytic characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer. The totality of the evidence for biosimilarity supported extrapolation of the data to support licensure as a biosimilar for other approved indications of U.S.-licensed Avastin, without the need of additional clinical studies. Clin Cancer Res; 24(18); 4365-70. ©2018 AACR.
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Texto completo: 1 Coleções: 01-internacional Temas: Epidemiologia / Geral / Tipos_de_cancer / Pulmao Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos / Medicamentos Biossimilares / Bevacizumab Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2018 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Temas: Epidemiologia / Geral / Tipos_de_cancer / Pulmao Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos / Medicamentos Biossimilares / Bevacizumab Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2018 Tipo de documento: Article