Contribution of animal studies to evaluate the similarity of biosimilars to reference products.
Drug Discov Today
; 20(4): 483-90, 2015 Apr.
Article
en En
| MEDLINE
| ID: mdl-25463036
ABSTRACT
The European Union (EU) was the first region to establish a regulatory framework for biosimilars, in which animal studies are required to confirm similarity to a reference product. However, animal studies described in European public assessment reports (EPARs) or marketing authorization applications (MAAs) did not identify clinically or toxicologically relevant differences despite differences in quality, suggesting that animal studies lack the sensitivity to confirm biosimilarity. Scientific advice provided learning opportunities to evolve existing guidance. Altogether, the data support a step-wise approach to develop biosimilars that focuses on quality and clinical efficacy of biosimilar. This approach might be more effective and does not necessarily require animal studies, which is also reflected in new EU draft guidance.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Aprobación de Drogas
/
Evaluación Preclínica de Medicamentos
/
Biosimilares Farmacéuticos
Tipo de estudio:
Etiology_studies
/
Guideline
/
Prognostic_studies
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Drug Discov Today
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2015
Tipo del documento:
Article