Insulin Biosimilars

There are an increasing number of biosimilar insulins on the market. All biological medicines, including biosimilar insulins should be prescribed by brand name so that products cannot be automatically substituted at the point of dispensing. Although the generic description is the same, these products are not all considered equivalent and are not all interchangeable.

It is particularly important to ensure that the patient receives the insulin intended for use with a delivery device that the patient is trained to use and has all the necessary items such as compatible needles and pen devices.

The MHRA has mandated that all biosimilars are labelled with a black triangle for the first few years after approval to signal to clinicians that they are subject to additional monitoring.

As a result of the more complex approval process for biosimilars, they are not as cheap as generic drugs to manufacture but are normally 30-70% of the price of the original therapy. This encourages commissioners within the NHS to include the biosimilars in their medicines optimisation programmes and many patients will be initiated or switched onto them, if clinically appropriate.

Advice for Community Pharmacy Teams:

• Familiarise yourself with the different insulin biosimilars and understand which are not equivalent or interchangeable
• Encourage local prescribers to always write prescriptions by brand name for insulin biosimilars to reduce the risk of dispensing an incorrect item
• Place warnings on the PMR system to remind colleagues to select the correct brand when dispensing, ensuring that continuity of brand is maintained
• Check with patients or their representatives or prescriber to confirm the product dispensed was the expected medicine
• Make patients are aware there are more than one version of the products and ask them to check before using the product
• Report any adverse reaction to an insulin biosimilar via the Yellow Card scheme to the MHRA so that appropriate monitoring can take place

Insulin Aspart

Fiasp is a formulation of insulin aspart that includes nicotinamide (vitamin B3) to increase the speed of absorption. In pharmacokinetic studies in patients with type I diabetes, the onset of appearance of insulin in the bloodstream was twice as fast with Fiasp® as with NovoRapid® (4 minutes vs 9 minutes). As such, it is not considered equivalent and is not interchangeable with NovoRapid®.

Studies have shown that Trurapi® has a similar pharmacokinetic and pharmacodynamics profile and comparable efficacy, safety and tolerability to NovoRapid® so can be considered equivalent.

Insulin Lispro

Admelog® has a similar pharmacokinetic and pharmacodynamics profile to the originator product Humalog® and as such needs no dose conversion, so can be considered equivalent.

Lyumjev® has two ingredients to accelerate its absorption, treprostinil to induce local vasodilation and citrate to increase local vascular permeability. It has a faster onset of action and shorter duration and is not equivalent or interchangeable with the originator product Humalog®.

Insulin Glargine

Both Abasaglar® and Semglee® show similar pharmacokinetic and pharmacodynamics profiles to the originator product Lantus® so can be considered equivalent.

Toujeo® is a 300 units/ml formulation of insulin glargine. In patients with type I diabetes, the glucose-lowering effect of insulin glargine 300 units/ml was more stable and prolonged than that of insulin glargine 100 units/ml. This effect is thought to be due to the lower injection volume of the high-dose formulation, which results in a smaller depot surface area. Care should be taken to ensure that this high strength version is not mistakenly selected when dispensing prescriptions for insulin glargine 100 units/ml.

More information on the individual products can be found in the Electronic Medicines Compendium