Different by Design: The Impact of Drug Delivery Device Design on the Future of the Biosimilars Market
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The pharmaceutical market is in a period of transition as the introduction of new biosimilars increases. This is only set to continue, as between 2018 and 2023, 17 original reference biologics are coming off patent, thus offering an important window of opportunity to manufacturers of competing biosimilars.[i]
Our conservative estimate on the market opportunity represented in Europe for biosimilar manufacturers suggests that this could be equivalent to $3.12 billion per year based on current revenues. The equivalent market opportunity in the USA equates to $5.24 billion per year. A lesser known but albeit important factor influencing the success of this transitional period is delivery device design of such biosimilars.
Healthcare regulators, managers and clinicians around the world are keen to harness the cost reductions and wider access to treatment that biosimilar competition enables, but the process of switching patients from original biologics to biosimilars is a not necessarily straightforward. It is surrounded by a number of both clinical and regulatory issues.[ii] Confidence in biosimilars by patients and physicians, more competitive pricing and confidence in the drug delivery device are additional key concerns.
Drug Delivery device plays a critical role
A growing volume of evidence shows that the design of the device for subcutaneous delivery of biologics, typically an auto-injector or pre-filled syringe, in fact plays a critical role in facilitating the switch from biologic to biosimilar.[iii] In particular, the Food and Drug Administration (FDA) has set a requirement that human factor studies are conducted to both support the device design and demonstrate that user associated risks have been understood and mitigated for the final combination product. Specifically, larger molecule biological drugs tend to be more viscous and can present challenges regarding the volume of drug to be delivered, ease of administration as well as potential pain on administration. As these treatments can be administered as frequent as weekly, this requires consideration.
Additionally, many healthcare systems are encouraging the adoption of self-administration within the home for chronic diseases to reduce the heavy burden on their systems and enable patients to access treatment in a more familiar and relaxed setting. Therefore, usability of drug delivery devices, especially for patients suffering from debilitating degenerative pathologies that may affect their mobility, is even more important.
New "combination products" as designated by the FDA clearly illustrate the role of device design in the delivery of effective therapies. New designs that have been specifically developed for biosimilar drugs often offer improved features that favour patient usability. Greater ease of use is certainly an important driver to encourage new users to follow their treatment plan, while existing users are likely to increasingly favour usability over habit especially when suffering from degenerative diseases such as ulcerative colitis, Crohn's disease, rheumatoid or osteoarthritis and many others. A number of pharma companies are even making moves to seek exclusive arrangements with device manufacturers to gain competitive edge in the switching/retention process.[iv]
Some useful guidelines on how to respond to these issues via device design have been summarized and reveal that special importance needs to be placed on ensuring devices are easy to handle and also minimise the risk of needlestick injury. These typically take the form of an autoinjector or pre-filled safety syringes that ensure dosage accuracy for patient safety, storage and disposal safety for carers and other residents within the home or care home environment such as other patients or cleaning staff.
It is clear that the delivery device design has taken an important role in the healthcare market especially as home administration becomes more prevalent. Our estimates expect it to also take on an increasingly important role in the future of competition within the biosimilars market. It is therefore clear that close attention needs to be placed on device design to ensure that competitive advantage is not lost, and that device design provides a supporting role through optimal usability and safety.
[i] Owen Mumford Pharmaceutical Services, Competitive Entry, November 2019
[ii] Such as: Current Medical Research and Opinion, L.McKinley(U.S. Regulatory Policy), J.M. Kelton (U.S. Medical Affairs), R.Popovian (U.S. Government Relations), Sowing confusion in the field: the interchangeable use of biosimilar terminology, 6 Sep 2018
[iii] European Medical Journal, Filipe C. Araújo,1,2 Joao Eurico Fonseca,3,4 Joao Goncalves,5Switching to Biosimilars in Inflammatory Rheumatic Conditions: Current Knowledge, EMJ Rheumatol. 2018;5:66-74; GABI Online, Alternative delivery devices for biosimilars, 1 Jun 2012
[iv] In-pharma Technologist, Pharma turning to injectable systems to protect biologics, 22 Jun 2015