Type 1 diabetes

Concern over biosimilar insulin substitution


A proposed move to allow pharmacists to substitute cheaper biosimilar insulins for originator brands could harm patients, Diabetes Australia has warned.

In a submission to the National Health Amendment (Pharmaceutical Benefits) Bill 2015 the organisation said it was strongly opposed to “a flagging” of pharmacy level substitution of any biosimilar insulin product.

Unlike generics, biosimilars were different in composition from their originator, the organisation explained.

“There is not yet any evaluation of the impact on a person’s management of their diabetes if they alternate between originator and substituted medication over the long term,” they wrote in their submission.

The proposed changes could result in a patient having their insulin switched without the knowledge of their diabetes healthcare team.

Changes in dosage amounts between the original and the biosimilar as well as differences in delivery devices could also cause confusion to patients.

The organisation was also concerned at the lack of consultation with diabetes consumers or diabetes health professional experts in Australia on the matter of biosimilars.

“No “a flagging” or pharmacy level substitution of biosimilar insulins should be considered until after there has been broad ranging consultation with the diabetes sector including consumers, diabetes health professionals and experts in fields such as pediatric endocrinology, diabetes in pregnancy and other,” it concluded.

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