Similar biotherapeutic products: overview and reflections.

overview and reflections

Zayrho Desanvicente-Celis, Arley Gomez-Lopez, Juan Manuel Anaya

Resultado de la investigación: Contribución a RevistaArtículo de revisión

3 Citas (Scopus)

Resumen

Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.

Idioma originalEnglish (US)
Páginas (desde-hasta)1841-1857
Número de páginas17
PublicaciónImmunotherapy
Volumen4
N.º12
DOI
EstadoPublished - dic 2012

Huella dactilar

Biosimilar Pharmaceuticals
Autoimmune Diseases
Medicine
Pathology
Safety
Neoplasms

Citar esto

Desanvicente-Celis, Zayrho ; Gomez-Lopez, Arley ; Anaya, Juan Manuel. / Similar biotherapeutic products: overview and reflections. overview and reflections. En: Immunotherapy. 2012 ; Vol. 4, N.º 12. pp. 1841-1857.
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Similar biotherapeutic products: overview and reflections. overview and reflections. / Desanvicente-Celis, Zayrho; Gomez-Lopez, Arley; Anaya, Juan Manuel.

En: Immunotherapy, Vol. 4, N.º 12, 12.2012, p. 1841-1857.

Resultado de la investigación: Contribución a RevistaArtículo de revisión

TY - JOUR

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AU - Anaya, Juan Manuel

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AB - Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.

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