The patent for Lantus® (Insulin glargine) has expired and a biosimilar preparation called Abasaglar®, which has a lower cost, has been launched. It has yet to be considered in the Local medicines decision making process, guidance for use with defined patient criteria is pending.
NB: The administration devices for Lantus and Abasaglar are slightly different. Lantus uses the Solostar pen, and Abasaglar the Kwikpen device.
Existing patients should continue to receive Lantus. Patients should not be routinely switched between brands.
Automatic substitution, defined here as the practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber is not appropriate for biological medicines, including biosimilar medicines and is not permitted at this time. Prescribers, of course, are always able to switch treatments for a given patient, provided it is safe to do so and there are appropriate monitoring arrangements in place.
As biosimilar medicines often use the same international non-proprietary name (INN) as their reference product, the main way to ensure automatic substitution does not take place is through brand name prescribing. Brand name prescribing should be adhered to by all prescribers for biological medicines, including biosimilar medicines, and is in line with recommendations from the MHRA and NICE, as well as being enshrined in EU law.
It is essential that patients stay on the same brand. All prescribing should be by Brand Name as recommended in local prescribing guidance for all insulin prescribing.
In primary care we recommend that all practices search for any patients currently prescribed insulin glargine generically and change to the existing branded product, Lantus® before Abasaglar® becomes more widely available, to avoid later confusion.
Pharmacists should dispense the brand ordered and not substitute. If a brand is not specified the prescription needs to be returned to the prescriber for this to be added.
Please note that pharmacists will not dispense insulin glargine unless prescribed by brand as they are not authorised to amend prescriptions.
Administration/ record keeping
It is important that a record is kept within the patient’s notes of the brand used. This is to facilitate reporting of adverse effects.
Adverse reactions (whether suspected or established) should be documented on Yellow Card reports to the MHRA as previously.