An increasing number of patents for biological medicines are now expiring – driving new growth in biosimilars. This, in turn, is throwing a spotlight on the issue of drug delivery device switching.
Developers of biosimilars need to differentiate their offerings from originator products – and a novel drug delivery device can be an attractive option. After all, patients are used to changes in the brands of drugs they are prescribed so it’s tempting to think they won’t be fazed by a new delivery device from a different manufacturer.
But it’s not as simple as that. If a patient has been using the same auto-injector for years, they may struggle to cope with a new one – or they may be afraid of unfamiliar features. Patient confidence is key – otherwise there’s a danger they won’t use the new device and will miss out on vital doses of medication.
The stakes are high – particularly given the growing trend for self-administration by patients at home (and, therefore, away from the watchful eyes of healthcare professionals). But if you get it right, it’s a win-win situation; patients are more likely to adhere to their treatment regimen if they find it easy to use their drug delivery device. This isn’t just good for the patient – it also benefits the healthcare system and pharmaceutical companies.
So how much change can patients cope with when it comes to their drug delivery device? The only way of knowing is to put a new device to the test with real patients. However, there is a surprising shortage of studies on the ease of switching devices – and that’s why we decided to commission an independent study to evaluate the ease with which patients were able to switch between two different auto-injectors.
Credit: Author supplied
The two devices chosen for the study were SHL Medical’s three-step, button-activated DAI auto-injector and our own OMPS two-step, spring-powered Aidaptus device, which does away with the push-button and is activated by the patient simply pressing the device onto the injection site. As well as making it easy for patients to use, we designed Aidaptus to accommodate both 1 mL and 2.25 ml prefilled glass syringes in the same base device – with stopper sensing technology and a self-adjusting plunger that automatically adapts to the different fill volumes in each syringe.
We believe our device brings benefits, but what about the patients who will – quite literally – be at the sharp end? To be clear, our aim wasn’t to compare the two devices (all study participants had already been using the DAI auto-injector for at least three months). We simply wanted to know how easy it was for the patients to switch from their familiar device to a new auto-injector.
There were 52 participants (34 women and 18 men) with an average age of 51 (age range 16–75) split equally between the UK and the US. They were each asked to carry out four injections into an injection pad on a table – starting with the DAI auto-injector and then alternating with the Aidaptus.
They were given no help with the new device – just the instructions for use (IFU) in the box containing the device. We wanted to see if they could successfully carry out injections with the new Aidaptus auto-injector without any external prompting or training. We were also interested to see how long they took to do the injections, whether they actually read the IFU (or even looked at them!), and how confident they were in performing the injections. Watching the participants handling the new device certainly provided us with some clues as to how easy to use they found it.
All the injections were carried out successfully – even with the unfamiliar device. Most participants only needed to examine Aidaptus once to deliver injections successfully, with the ability to switch between the two devices not affected by gender. Those aged over 40 took slightly longer to deliver the injections with both devices – but still completed them successfully. Interestingly, by the second use, the injection times – calculated from when a participant placed the auto-injector on the injection pad and started the injection process through to when the device was removed from the pad – were similar for both devices.
Of course, although these results are interesting, they are obviously just a start – we need many more user studies to really understand all the potential pitfalls when it comes to asking patients to switch to an unfamiliar drug delivery device. Nevertheless, it was reassuring for us to see that the study participants managed to take it all in their stride – even when under pressure in an artificial test environment.
And I’ll cheekily add that our results suggest that choosing an innovative two-step auto-injector for biosimilars instead of a traditional three-step device may not be a step too far after all!
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