
Australia Allows Pharmacy-Level Substitution of Biologics
The decision makes Australia the first and only nation to permit automatic substitution of biosimilars.
Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) of Australia recently announced that Australia will not require physician notification when substitution of a biologic medicine occurs at the pharmacy level, giving pharmacists the autonomy to automatically substitute one medication for another.
On June 19, 2015, Minister Ley’s office released a
There is no interchangeability requirement associated with the switching of medicines through the PBS. Unlike much of the proposed state-level legislation in the US, the recommendation does not appear to require that pharmacists notify physicians or patients of a substitution, nor does it specify that pharmacists must keep a log of the substitution. Although Minister Ley said physicians would “still have a say” on whether substitution would be appropriate, patients “would still have the ultimate choice regarding whether they receive the biologic medicine or the biosimilar at the chemist when they fill their script.”
Some opponents of Ley’s decision say the move has the potential to reduce the standards of safe use of biosimilars and could put patients at risk. “Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia,” said Stephen Murby, former chair of the Consumers Health Forum and an ASBM Advisory Board member, in an
Mona Marabani, MD, president of the Australian Rheumatology Association (ARA), said that the safety with switching from biologics to biosimilars has not been proven. “Scant evidence exists regarding switching to a biosimilar in people with autoimmune arthritis who are stable or in remission on the original biologic," she
In a
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