As a growing number of biologics reach their patent expiry date and markets continue to open up to biosimilar manufacturers, competition for a number of drugs will continue to grow. This window of opportunity for biosimilar manufacturers could be highly profitable, with our own research estimating the biosimilar market opportunity to be $5.24 billion on average per year in the U.S. over a five-year period.¹ Payors and patients could also stand to benefit from this development, as these newcomers spur competition, leading to a reduction in the cost of medications and an associated increase in access and choice. In fact, introducing biosimilars of complex biologic drugs could cut healthcare spending in the U.S. by $54 billion over the next decade.² In the European Union, biosimilars have already generated a price discount which hovers around the 30% mark.³

This market incentive, however, may not in itself be enough to drive biosimilar uptake. If they are to stay ahead of the curve within this increasingly competitive market, biosimilar manufacturers will need to factor in several crucial non-price aspects into their product offering. In this article, we examine some of the key factors for injectable combination products which are seen to be decisive in encouraging or discouraging switching, and allowing biosimilar manufacturers to keep ahead of the competition.

Confidence in biosimilar products
Given that there is often some reservation towards new products that haven’t had years of use in the field, switching patients from original biologics to biosimilars is not necessarily a straightforward procedure. Yet, the adoption of biosimilars will largely depend on the confidence of clinicians in biosimilar products. Even if similar in terms of their structure, biological activity and immunogenicity profile, biosimilars can never be an exact replica of the original product. This is likely a source of concern when swapping from one product to another.

While independent studies⁴ have started to alleviate some of the initial concerns about their use, data supporting the efficacy and safety of the medicinal component of biosimilar products is still required. The FDA, for instance, requires submission of robust pharmacokinetic and dynamics study data and sometimes also supporting clinical studies in order to grant product approval and marketing authorization. In the long-term, this thorough evaluation combined with growing real-world evidence will strengthen the level of confidence in biosimilars.

Moreover, healthcare regulators, managers and clinicians are proactively encouraging adoption where appropriate, in light of the benefits that come with biosimilar competition.

Trust in the ancillary drug delivery device
Beyond confidence in biosimilars as an efficient and safe biologic alternative, confidence in the drug delivery device is another essential consideration. A growing body of evidence⁵ shows that the design of the drug delivery device can be instrumental to facilitating a switch in either direction. This is particularly true in an age of growing self-administration by patients in a home environment or other non-traditional healthcare settings. Biosimilar manufacturers may be accustomed to designing their injectables with healthcare professionals in mind. With the rise of self-administration, however, they are now being made to adapt to meet the safety and ease-of-use concerns of a diverse pool of patients who are increasingly involved in their own medication delivery.

In this context, the simplicity and intuitiveness of a device can function as influencing factors for patient adherence. Furthermore, patients with chronic conditions may experience gradually diminishing dexterity, making ease of use doubly critical. Devices such as auto-injectors and pre-filled safety syringe designs should ideally require minimum effort and dexterity from patients during administration, be intuitive to use and help minimize the risk of dosage errors or drug wastage. For the adoption and adherence of a biosimilar injectable to be successful, manufacturers will therefore benefit from looking beyond price reduction strategies and the efficacy of the product’s medicinal component, and working to earn patient trust in the ancillary drug delivery device that may be used to inject the therapy.

Safety and regulations
Compliance with safety regulations for needlestick prevention is another key factor that manufacturers will need to address, for which they are advised to partner with a device manufacturer who provides safety-engineered devices. Features that strengthen the safety of a device may encourage existing users to accept a loss of familiarity and habit. Equally, safety devices help protect healthcare workers—whether they are hospital-based or home workers—against potential infection through sharps injuries. In particular, automatic or passive needle-shielding safety mechanisms are a beneficial feature in injection devices as the patient is not required to perform any additional step after the injection procedure to protect themselves or others.

Evidence of human factors studies
It is vital that manufacturers carry out human factor studies to support the design of their drug delivery device. Human factors (HF) studies are fundamental to identifying and minimizing any user-associated risks that the device may present during the medication administration procedure. These tests must be comprehensive. In addition, factoring in compliance with the ISO10993 standard for biocompatibility of materials for cytotoxicity, irritation and skin sensitization is also crucial. Manufacturers must be able to demonstrate that they have thoroughly assessed and addressed all aspects of risk associated with the product in typical user environments.

Proven manufacturability and durability
Designing for simple manufacture and assembly are also key considerations in the device design process. While some device designs may seem more innovative, it is crucial that biosimilar manufacturers stay clear of designs which may be detrimental to the product’s manufacturability.⁶ In fact, usability and robustness, assembly and manufacturing risk management, supply chain reliability, environment and disposal risks, as well as post-shipping device performance must all be factored into the development process of the device, as a variety of commentators have suggested.⁷ Ensuring post-market monitoring is another invaluable procedure which can be used to later feed back into the design process, strengthening manufacturers’ understanding of their end-users, and demonstrating their commitment to meet patient needs.

The ‘patent cliff’ has opened the market to biosimilar products, but manufacturers cannot rely solely on price reduction to gain a strong share in the market. To compete against other biosimilar manufacturers, close attention must be paid to drug delivery device design to encourage uptake and long-term adoption. More specifically, the rise of self-administration has rendered ease of use, comfort and convenience important factors that can significantly influence patient adherence. If they wish to gain a competitive edge within this lucrative market, biosimilar manufacturers will need to attribute special attention to every stage of device production, from patient usability and safety to manufacturability and packaging. 


References

1. Owen Mumford, Competitive Entry, November 2019.
2. PharmaVoice, The Biosimilars Market, May 2019: https://www.pharmavoice.com/article/2019-05-biosimilars/
3. See, for instance, The Oncologist, C.Nabhan, A.Valley, B.A.Feinberg, Barriers to Oncology Biosimilars Uptake in the United States, Jul 2018, The Oncologist vol.23 no.11 1261-1265.
4. Such as American College of Rheumatology, Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway, 22 Oct 2016.
5. 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[1]:66-74; GABI Online, Alternative delivery devices for biosimilars, 1 Jun 2012.
6. FDA, Understanding Barriers to Medical Device Quality, 2011.
7. For instance: Pharmaceutical Online, M Song, 4 Important things to consider before designing a drug delivery device, 6 Aug 2019.