The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?
Expert Rev Gastroenterol Hepatol
; 9 Suppl 1: 27-34, 2015.
Article
em En
| MEDLINE
| ID: mdl-26395532
Biopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade(®)) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima(®), Inflectra(®)), has recently been approved in Europe for all indications in which infliximab is approved. Approval of CT-P13 was based in part on extrapolation of clinical trial data from two indications (rheumatoid arthritis and ankylosing spondylitis) to all other indications, including inflammatory bowel disease. This review discusses the validity of extrapolating immunogenicity data across indications - a process adopted by the EMA as part of their biosimilar approval process - with a focus on CT-P13.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Fármacos Gastrointestinais
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Doenças Inflamatórias Intestinais
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Fator de Necrose Tumoral alfa
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Medicamentos Biossimilares
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Infliximab
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Anti-Inflamatórios
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Anticorpos Monoclonais
Tipo de estudo:
Diagnostic_studies
Limite:
Animals
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Humans
Idioma:
En
Revista:
Expert Rev Gastroenterol Hepatol
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Israel