Diabetes groups have joined forces against moves to allow pharmacists to substitute biosimilar insulins, saying it has the potential to seriously disrupt diabetes management.
The joint statement from the Australian Diabetes Education Association, the Australian Diabetes Society and Diabetes Australia is in response to a PBAC recommendation to list the biosimilar insulin glargine product Basaglar on the PBS and allow pharmacists to substitute Basaglar insulin for the originator (Lantus insulin) or vice versa.
The diabetes groups say they are strongly opposed to biosimilar substitution at the pharmacy level due to “insufficient evidence of safety” and concern about the increased risk of hypoglycaemia which may be associated with switching insulins.
The Product Information for Basaglar insulin effectively rules out pharmacy level substitution by stating that the level of comparability was not sufficient to designate the product as a generic version of Lantus , the organisations noted in their statement.
“Replacement of Lantus with Basaglar, or vice versa, should take place only under strict medical supervision,” the product information notes.
“We support substitution of insulins under appropriate medical supervision and with the involvement of the diabetes healthcare team including diabetes educators and practice nurses,” the diabetes groups concluded.
There were other clinical considerations that needed to be taken to account, such as the subtle differences between insulin and biosimilar insulin delivery systems.
“The proposed changes mean in addition to an alternate insulin, patients could be supplied with different devices which they are not trained to use,” the position statement said.
The PBS is yet to announce its recommendation on pharmacy-level substitution of biosimilar insulins.
To read the full position statement click here.