dc.description.abstract |
Interchangeability of drug products has very different features
with small molecules and with biologicals. With small-molecule
drugs, a statement of bioequivalence generally indicates
therapeutic equivalence and interchangeability. In contrast,
with the much more sensitive and complicated biological drugs, a
declaration of biosimilarity emphatically does not imply that a
patient could be switched from one product to another. Both
formulations may be prescribed and administered to subjects who
have not received yet the drug in any of its forms. However,
regulatory agencies have been very cautious about enabling and
permitting interchangeability. Notably, the Biologics Price
Competition and Innovation Act of the USA sets very formidable
and severe conditions for enabling the interchangeability of
biological drug products. The background and conditions for the
interchangeability of both small-molecule and biologic drug
products are presented in detail. Copyright (c) 2012 John Wiley
& Sons, Ltd. |
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