Alex Fong, Head of Insight, Owen Mumford Pharmaceutical Services
Devices as Differentiators
Choosing the right injectable drug delivery device can be a crucial differentiator for pharmaceutical manufacturers – particularly as the market becomes increasingly crowded with biosimilars. But any decision on switching to a different device needs to be underpinned by firm evidence on the likely reaction from patients. After all, any drug is only as good as the patient’s adherence to their treatment regimen.
If a patient struggles to make the switch from a familiar auto-injector to an innovative new one, there is a danger they will be less inclined to use the device and therefore miss out on vital doses of medication. This issue is particularly important now that many treatments for chronic conditions are self-administered by patients at home, often without the support of a healthcare professional. Ease of use encourages patient adherence and therefore benefits the patient, the healthcare system – and pharmaceutical companies.
Device Interchangeability
Alongside the trend for home self-administration is the growth of biosimilars, as an increasing number of patents for biological medicines are now expiring. In the UK, the NHS expects to save up to £300 million a year by making more biosimilar alternatives available.1 Meanwhile, in the US, savings of $38.4 billion have been predicted for 2021–2025, compared with 2020, as the wider availability of biosimilar products creates a significantly more competitive market.2
Of course, as well as the cost savings of switching from originators to biosimilars, there also needs to be consideration of the most suitable device for administering the new drugs. To support the choice of this device, pharmaceutical companies should have access to data from human factors studies and any other user testing. This data can then support regulatory applications for determining device interchangeability.
The FDA requires a regulatory application to provide evidence that the impact of switching between delivery devices has been assessed, stating: “Data and information supporting the appropriate use and performance testing of the delivery device constituent part of the proposed interchangeable product should be submitted.”3 In Europe, the European Medicines Agency allows differences in the administration device, as long as there is no impact on safety and efficacy.
INTERCHANGEABILITY STUDY
Study Objectives
To provide pharmaceutical companies with evidence for making delivery device decisions for their drugs, there is a need for more studies on the ease of switching devices. This prompted Owen Mumford Pharmaceutical Services (OMPS) to commission an independent study to evaluate the ease with which patients were able to switch between two different auto-injectors.
Auto-injectors are routinely used to deliver biologics suitable for subcutaneous administration. They are convenient for patients and allow them to administer medication in their own homes without requiring the presence of a healthcare professional. The OMPS study aimed to discover whether regular users of a market-leading three-step auto-injector were able to switch to a new two-step auto-injector and successfully perform injections.
Study Design
The three-step auto-injector used in the study was SHL Medical’s button-activated DAI® device – one of the first auto-injectors to be commercialised for home injection (4). The two-step auto-injector was the spring-powered Aidaptus® device from OMPS (5), which uses pressure to activate the injection – rather than having to push a button, the patient simply presses the device onto the injection site.
