We speak with Professor Begoña Calvo from University of the Basque Country in Spain to find out more about her research into pharmacovigilance for biosimilars.
Stephanie Sutton |
How is a biosimilar different to a generic?
Biosimilars are biological medicines with active substances that are highly similar, but not identical, to those of biologics that have already been authorized. To receive approval for a generic, you only need to show bioequivalence compared to the originator.
Biosimilars are approved via a stringent regulatory pathway that involves demonstrating quality, safety and efficacy comparable to the original product. Biosimilars cannot be classified as ‘generics’ in the same way that chemical compounds are because of the variability of the active biotechnological substance and its complex manufacturing process.
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