Monoclonal antibody: the corner stone of modern biotherapeutics / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1275-1280, 2012.
Artículo
en Inglés
| WPRIM
| ID: wpr-274665
ABSTRACT
Worldwide sales of biologic drugs exceeded 100 billion USD in 2011. About 32% is from therapeutic monoclonal antibody (mAb). With many blockbuster biopharmaceutical patents expiring over the next decade, there is a great opportunity for biosimilar to enter the worldwide especially emerging market. Both European Medicines Agency (EMA) and Food and Drug Administration (FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb therapeutics. Rather than providing a highly abbreviated path, as in the case for small molecule chemical drug, approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case basis. Since mAb is the dominant category of biologic drugs, mAb will be the focus of this review. First, the United States (US) and European Union (EU) approved mAb and those in phase 3 trials will be reviewed, then strategies on how to win biosimilar competition will be reviewed.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Estándares de Referencia
/
Estados Unidos
/
United States Food and Drug Administration
/
Aprobación de Drogas
/
Ensayos Clínicos Fase III como Asunto
/
Anticuerpos Biespecíficos
/
Usos Terapéuticos
/
Unión Europea
/
Anticuerpos Monoclonales Humanizados
/
Biosimilares Farmacéuticos
Tipo de estudio:
Ensayo Clínico Controlado
Límite:
Animales
/
Humanos
País/Región como asunto:
America del Norte
Idioma:
Inglés
Revista:
Acta Pharmaceutica Sinica
Año:
2012
Tipo del documento:
Artículo
Similares
MEDLINE
...
LILACS
LIS