Abstract
Biological products are very complex molecules, therefore the same regulatory
approach of assessing chemical drugs cannot be used. Although a variety of assays are
available, they may not be adequate to reliably predict the safety and efficacy of
biological products. Several studies indicated that the treatment responses of biological
products are not the same especially the immune responses. This study was a
descriptive study conducted by intensive literature reviews and group discussions. The
result showed that the dossiers of registered biological products were partially
incomplete comparing with international guidelines, which may cause the risk over
benefit. Thus, researchers have proposed a future system to regulate biological products
by shifting the registration and re-evaluation paradigms of biological products to be in
compliance with current international guidelines on biological products and biosimilars.
The implementation of this new proposed system requires the development of
administrative and technical aspects.
