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Biosimilar diabetes medication available from 1 October 2019

Recent PBS reforms allow substitution of biosimilar drugs at the pharmacy level.

In September 2019, ADEA, ADS and Diabetes Australia released a position statement on the use of biosimilars for diabetes. In summary:

“Diabetes Australia, the Australian Diabetes Society and the Australian Diabetes Educators Association are strongly opposed to biosimilar substitution at the pharmacy level due to insufficient evidence of safety.

We support substitution of insulins under appropriate medical supervision and with the involvement of the diabetes healthcare team including diabetes educators and practice nurses.

Over 370,000 Australians with diabetes are currently using insulin therapy and pharmacy level substitution has the potential to seriously disrupt diabetes management for large numbers of people with diabetes. We have particular concerns about the increased risk of hypoglycaemia which may be associated with switching insulins.”

With the recent listing of an insulin glargine biosimilar (Basaglar insulin, “Semglee”), your patients who are currently prescribed Lantus may receive the biosimilar medication from 1 October 2019. The TGA Product Information advises: “The level of comparability that has been shown is not sufficient to designate this product as a generic version of Lantus. Replacement of Lantus with Basaglar, or vice versa, should take place only under strict medical supervision.”

Our position statement notes that there are important clinical considerations for health professionals:

“…the main delivery source of insulin in Australia is through high-precision, pen delivery devices designed to deliver exact doses of insulin. This is critical to patient wellbeing. Subtle differences between insulin and biosimilar insulin may not be clinically significant but it can render a delivery device less effective or ineffective. This could have major consequences for a person’s health.
Each manufacturers’ devices are different and patients are provided specific training from healthcare professionals about their specific device when they commence insulin therapy. Pharmacy staff are often not familiar with, nor trained in the use of, these devices.

The proposed changes mean a patient could have their insulin switched at the pharmacy level, without the knowledge of their diabetes healthcare team. That means, in addition to an alternate insulin, patients could be supplied with different devices which they are not trained to use.

Changes in dosage amounts between the original and the biosimilar could also cause confusion and inappropriate dosage.

The pharmacist dispensing the biosimilar insulin may not be aware of the previous reactions the patient has had with alternate insulin sources.

You can read the full position statement here.

The manufacturer of Lantus, Sanofi-Aventis Australia, has written to medical practitioners this week advising of these changes. A copy of the letter is attached for your information.