Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 26

An important consideration with all biologics is unwanted immunogenicity as biologics are often manufactured in living cells of nonhuman origin. Unwanted immunogenicity may lead to a reduction or loss of efficacy, altered pharmacokinetics, general immune and hypersensitivity reactions, and neutralization of the natural endogenous counterpart.⁴⁶ Immunogenicity of biosimilars would be expected to mirror those of the innovator biologic based on the similarity principle.⁴⁷