Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab.
BioDrugs
; 33(3): 321-333, 2019 Jun.
Article
em En
| MEDLINE
| ID: mdl-30972630
ABSTRACT
BACKGROUND:
ABP 980 has been developed as a biosimilar to Herceptin® (trastuzumab). Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare ABP 980 to trastuzumab reference products sourced from the United States (US) and the European Union (EU).METHODS:
Physicochemical property comparisons included the following primary structure related to amino acid sequence and post-translational modifications, including glycans; higher-order structure; product-related substances and impurities, including size and charge variants; subvisible and submicron particles, and protein content. In addition, functional similarity was assessed for Fab-mediated, Fc-mediated, and combined Fab- and Fc-mediated activities.RESULTS:
ABP 980 has the same amino acid sequence as and similar post-translational modification profiles to trastuzumab (US) and trastuzumab (EU). Importantly, ABP 980 was found to be highly similar to trastuzumab for all functional activities related to the mechanism(s) of action. Higher-order structure, product-related substances and impurities, particles and aggregates were also highly similar between ABP 980 and trastuzumab. Where minor differences were noted, they were evaluated and found unlikely to impact clinical performance. The totality of evidence, including the pharmacokinetic clinical similarity of ABP 980, further supports that ABP 980 is highly similar to trastuzumab.CONCLUSION:
Based on the comprehensive analytical similarity assessment, ABP 980 is analytically highly similar to the reference product, trastuzumab.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Medicamentos Biossimilares
/
Trastuzumab
Limite:
Humans
País/Região como assunto:
America do norte
/
Europa
Idioma:
En
Revista:
BioDrugs
Assunto da revista:
ALERGIA E IMUNOLOGIA
/
GENETICA MEDICA
/
TERAPEUTICA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Estados Unidos