Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.
Drug Discov Today
; 18(17-18): 872-9, 2013 Sep.
Article
en En
| MEDLINE
| ID: mdl-23688584
ABSTRACT
Biosimilars have been available on the European market since 2006 and experience with their use is increasing. The next wave of biopharmaceuticals that are about to lose patent protection consists of more-complicated products, including many monoclonal antibodies. Guidance has been released on the particulars of a biosimilarity exercise involving these products. Considerable challenges exist to establish biosimilarity for anticancer products. An especially challenging product is bevacizumab (Avastin(®)). On the basis of data available for the innovator product (bevacizumab) we will discuss strengths and weaknesses of preclinical and clinical models and explore the application of novel endpoints to the biosimilar comparability exercise.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Inhibidores de la Angiogénesis
/
Anticuerpos Monoclonales Humanizados
/
Biosimilares Farmacéuticos
Tipo de estudio:
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Drug Discov Today
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2013
Tipo del documento:
Article
País de afiliación:
Países Bajos