Key considerations in the preclinical development of biosimilars.
Drug Discov Today
; 20 Suppl 1: 3-15, 2015 May.
Article
em En
| MEDLINE
| ID: mdl-25912284
ABSTRACT
Biosimilar development requires several steps:
selection of an appropriate reference biologic, understanding the key molecular attributes of that reference biologic and development of a manufacturing process to match these attributes of the reference biologic product. The European Medicines Agency (EMA) and the FDA guidance documents state that, in lieu of conducting extensive preclinical and clinical studies typically required for approval of novel biologics, biosimilars must undergo a rigorous similarity evaluation. The aim of this article is to increase understanding of the preclinical development and evaluation process for biosimilars, as required by the regulatory agencies, that precedes the clinical testing of biosimilars in humans.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Indústria Farmacêutica
/
Avaliação Pré-Clínica de Medicamentos
/
Medicamentos Biossimilares
Tipo de estudo:
Etiology_studies
/
Guideline
/
Risk_factors_studies
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Drug Discov Today
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2015
Tipo de documento:
Article