It is well-known that a number of original reference biologics have reached their expiry date for patent exclusivity in the past years (also known as the patent cliff). In Europe, seventeen biologics will have come off patent during the 2018–2023 period alone. For biosimilar manufacturers, this represents an important opportunity to significantly advance their market share against original biologics.
Based on current revenues, we cautiously estimate this market opportunity to be US$3.12 billion per year for biosimilar manufacturers — even after factoring in competitive discounts and based on a 50% market share — and there is an expectation that this number will only continue to grow … with the EU already having 54 approved biosimilar products.1,2
The ability for biosimilar manufacturers to succeed within this newly competitive market, however, will depend on several factors.
It is no surprise that the injection of these biosimilars into the market will improve market competition and lead to an inevitable reduction in the cost of biologics, to the benefit of pressurised healthcare systems and patients worldwide. In fact, the greater availability of drug choice has already been seen to generate price discounts that cluster around the 30% mark in Europe in spite of some outliers.3
In the longer term, this price reduction will need to stabilise at a level that doesn’t jeopardise the commercial incentive for pharmaceutical manufacturers to continue investing in new drug discovery, development and regulatory approval.
Regulators such as the US FDA are demanding an increasing level of data to support biosimilar approval
Even considering this cost incentive, switching patients from original biologics to biosimilars is not necessarily a straightforward procedure. Crucially, the current lack of concrete evidence demonstrating clear interchangeability between the original reference biologics and their respective biosimilars is not negligible and regulators such as the US FDA are demanding an increasing level of data to support biosimilar approval.
Independent studies are beginning to fill this gap in evidence, showing the transition to be well-tolerated by patients.4 Furthermore, healthcare regulators, managers and clinicians have a clear interest in harnessing the cost reductions and improved access to treatment enabled by biosimilar competition.
In the UK, the NHS is now actively encouraging a more collaborative approach between commissioners, providers and patients to realise the savings from switching to biosimilar medicines.5
Critical to a smooth switch between an original biologic and a biosimilar is patient and physician confidence in the product, notably self-administrating patients’ confidence in the drug delivery device. A growing volume of evidence has shown that the design of the subcutaneous injection device plays a fundamental role in facilitating the switch.6
More specifically, ease-of-use ranks highly in these studies. The growing self-administration trend for the treatment of chronic illnesses requiring frequent injections has made patient usability more important than ever before and may even urge existing users to favour usability compared with habit and familiarity.
In this context, it becomes strategically vital that manufacturers do human factor studies to support the design of their device and identify and reduce any risks when in use. Being able to demonstrate that user-associated risks have been mitigated will be a key means of facilitating patient adherence while also acting as a competitive distinguisher within this highly competitive post-patent market.
In fact, pharmaceutical companies have been seen to seek exclusive arrangements with device manufacturers to secure a competitive edge during this process.7
Design and compliance
To dig deeper into the design details that should be considered during evaluation, it is firstly important to carefully select the primary container. This initial evaluation should pay attention to drug interaction and the impact of the container on drug stability, as well as its suitability with regards to the manufacturing processes involved.
Regulatory compliance should also be kept in mind at all stages of the design selection, particularly in light of the recent tightening of regulation for combination products.
Next, human factors studies must be undertaken in an all-encompassing manner, as well as factoring in ISO10993 accreditation for the biocompatibility of materials for cytotoxicity, irritation and skin sensitisation.
Among the list of things that will require testing, commentators suggest looking at robustness and usability, assembly and manufacturing risk management, supply chain reliability, environmental/disposal risks and post-shipping device performance.8
Manufacturers must keep this design review process as transparent as possible
Similarly, methods of operational transfer, packaging, shipping and post-market surveillance procedures will also need to be considered. Finally, manufacturers must keep this design review process as transparent as possible by putting together a fully documented design history file.
Evidently, making the right choices with regards to the delivery device design is going to play a particularly crucial role in being able to rise above the competition and encourage biosimilar adoption. Amid the rise of self-administration, ease of use, comfort and the convenience of these devices are becoming increasingly important factors that can significantly influence patient adherence.
With the likely available market for biosimilar manufacturers showing great lucrative potential, close attention must be placed on device design to successfully realise an uptake in biosimilar adoption and growing market shares.
Manufacturers will also need to look beyond patient usability and attribute special attention to every stage of the device production — from the selection of the primary container to manufacturability and packing considerations — if they wish to gain a competitive edge.
- C. Nabhan, A. Valley and B.A. Feinberg, “Barriers to Oncology Biosimilars Uptake in the United States,” The Oncologist 23(11), 1261–1265 (2018).
- G.L. Goll, et al., “Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway,” Arthritis Rheumatol. 68(Suppl. 10), Abstract 19L (2016).
- F.C. Araújo, J.E. Fonseca and J. Goncalves, “Switching to Biosimilars in Inflammatory Rheumatic Conditions: Current Knowledge,” EMJ Rheumatol. 5(1), 66–74 (2018).