Increased ‘Pharmacovigilance’ is Required with Biosimilar Medications Say Pharmacy Experts


At the beginning of this year, the FDA approved the first biosimilar insulin glargine, Basaglar, for type 1 and type 2 diabetes.

Biosimilar drugs, which span a wide range of types, are heralded by many for the potential to have lower costs than brand name medications.

In terms of insulin, Diatribe reports that “Basaglar has already launched in several international countries (under the brand name Abasaglar) and is typically priced at a 15%-20% discount relative to Lantus in those markets.”

However, as with any change in medication, people have become concerned about the safety of something they’ve never used before.

Writing in the Australian Prescriber, using the example of biosimilar insulin, pharmacy academics Ross McKinnon and Michael Ward discuss how biosimilar medications should be approached as having unique safety considerations for patients.

According to McKinnon and Ward, safety concerns should be made on a drug-by-drug basis.

“Early experience indicates that once biosimilars become available, initial safety concerns will decrease. However, there remains a need for appropriate pharmacovigilance which considers the unique properties of these drugs”.

McKinnon and Michael also point to the need for being mindful about the devices for administering insulin to be sure they are appropriate for different medications.

“Device design is proprietary so biosimilars will have a different device not only in appearance but also potentially in function. This could cause problems with safety”.

Although manageable through education, care needs to be taken to ensure that patients switching between products do not become confused. Currently, the naming conventions for biosimilars are still being established and that must be addressed.

McKinnon and Ward note that fundamental to the issue going forward is accurate documentation and reporting of the specific products for each patient.

This news article is based on current media reports concerning treatment. As always, you should consult your healthcare provider on all matters concerning your health and safety.