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      Bioequivalence and the immunogenicity of biopharmaceuticals.

      Nature reviews. Drug discovery
      Amino Acid Sequence, Animals, Antibody Formation, Biological Products, immunology, Glycosylation, Humans, Models, Animal, Therapeutic Equivalency

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          Abstract

          The expiry of the first patents for recombinant-DNA-derived biopharmaceuticals will open the possibility of marketing generics, if they can be shown to be essentially similar to the innovator product. However, as shown by the problem of immunogenicity, the properties of biopharmaceuticals are dependent on many factors, including downstream processing and formulation. Products from different sources cannot be assumed to be bioequivalent, even if identical genes are expressed in the same host cells and similar production methods are used. Some of the influencing factors are still unknown, which makes it impossible to completely predict biological behaviour, such as immunogenicity, which can sometimes lead to serious side effects.

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          Author and article information

          Journal
          12119747
          10.1038/nrd818

          Chemistry
          Amino Acid Sequence,Animals,Antibody Formation,Biological Products,immunology,Glycosylation,Humans,Models, Animal,Therapeutic Equivalency

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