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Perspective of biosimilars: A brief comment on immunogenicity of human insulin biosimilars based on viewing of severe adverse events of epoetin α and roferon A / 中华内分泌代谢杂志
Chinese Journal of Endocrinology and Metabolism ; (12): 637-641, 2013.
Artigo em Chinês | WPRIM | ID: wpr-442826
ABSTRACT
A number of biosimilars will be soon marketing due to the expiration of patent protection of their originators.Unlike classical chemical drugs,biotherapeutics are proteins with large and complex molecules produced by biological high-tech with sophisticated manufactural procedures.This leads to the difficulties of the copy of biosimilars from their originators,and the almost inevitable distinctions between the two products.Thus biosimilars are only similar but not identical to their reference drugs in terms of stracture,action,and safety.It is important for physicians to understand these differences before using biosimilars.Optimal management by a national regulatory authority with rigorous standards is very important in all aspects of authorization of the development,production,marketing,and postmarketing surveillances for biosimilars.

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Idioma: Chinês Revista: Chinese Journal of Endocrinology and Metabolism Ano de publicação: 2013 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Idioma: Chinês Revista: Chinese Journal of Endocrinology and Metabolism Ano de publicação: 2013 Tipo de documento: Artigo