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Nat Rev Drug Discov. 2002 Jun;1(6):457-62.

Bioequivalence and the immunogenicity of biopharmaceuticals.

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Central Laboratory Animal Institute, Department of Innovation Studies, Utrecht University, P.O. Box 80.190, 3508 TD Utrecht, The Netherlands.


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.

[Indexed for MEDLINE]

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