Biosimilars: in support of extrapolation of indications.
J Crohns Colitis
; 8(5): 431-5, 2014 May.
Article
en En
| MEDLINE
| ID: mdl-24594005
ABSTRACT
Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies. By successfully completing the biosimilarity exercise, the biosimilar shows that all aspects that are considered relevant for the clinical activity of the product fall within the same range as observed for the innovator. It should be carefully considered whether the benefit of additional information from more comparative clinical studies weighs up to the additional barriers such studies create for biosimilars to enter clinical practice.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Biosimilares Farmacéuticos
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
J Crohns Colitis
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2014
Tipo del documento:
Article
Pais de publicación:
ENGLAND
/
ESCOCIA
/
GB
/
GREAT BRITAIN
/
INGLATERRA
/
REINO UNIDO
/
SCOTLAND
/
UK
/
UNITED KINGDOM