THE Therapeutic Goods Administration (TGA) is seeking input from interested stakeholders on proposed options around whether there is a need in Australia for additional naming requirements for biological medicines as a way of strengthening traceability and pharmacovigilance.
At present there is no easy way to distinguish between originator and biosimilar products even though the products are not identical in every way, as in the case of small molecule drugs and their generics.
This makes it impossible to track adverse events with either originator or biosimilar product making it equally impossible to manage switching patients.
There is no internationally agreed naming convention for biosimilars, prompting the TGA to consult on the matter - consultation closes 08 Sep 17 - visit tga.gov.au to submit.
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