Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management.
Expert Rev Neurother
; 15(6): 597-600, 2015 Jun.
Article
en En
| MEDLINE
| ID: mdl-25924772
ABSTRACT
Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and efficacy. Unlike simple molecules that can be copied and reproduced, biosimilars and follow-on complex drugs are heterogeneous and need specific regulations from health and pharmacovigilance agencies. A panel of 14 Latin American experts on multiple sclerosis from nine different countries met to discuss the recommendations regarding biosimilars and follow-on complex drugs for treating multiple sclerosis. Specific measures relating to manufacturing, therapeutic equivalence assessment and pharmacovigilance reports need to be implemented before commercialization. Physical, chemical, biological and immunogenic characterizations of the new product need to be available before clinical trials start. The new product must maintain the same immunogenicity as the original. Automatic substitution of biological and complex drugs poses unacceptable risks to the patient.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Gestión de Riesgos
/
Control de Medicamentos y Narcóticos
/
Biosimilares Farmacéuticos
/
Factores Inmunológicos
/
Esclerosis Múltiple
Tipo de estudio:
Etiology_studies
/
Guideline
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Expert Rev Neurother
Asunto de la revista:
NEUROLOGIA
/
TERAPEUTICA
Año:
2015
Tipo del documento:
Article
País de afiliación:
Argentina