Biosimilars and drug delivery: where are the opportunities?
Lu Rahman speaks to Owen Mumford Pharmaceutical Services about the findings of its recent report scoping the near-term competitive biosimilars market in the USA and Europe, and its impact on drug delivery device design.
The available market for biosimilar manufacturers seeking to compete with original reference biologics coming off patent between late 2018 and 2023 in the USA and Europe, is considerable. However, says Owen Mumford Pharmaceutical Services, even where clinicians encourage the use of biosimilars for the patient, there remain some key considerations to overcome. This includes clinical confidence in the biosimilar; competitive pricing of drugs through greater competition; and patient confidence in the drug delivery device.
Owen Mumford Pharmaceutical Services' study reveals the size of the near-term opportunity in competitive biosimilars markets for biologics coming off patent 2018-2023, and offers evidence that device design is a key differentiator in addressing patient adoption.
In Europe, the estimated market opportunity for this five year cohort of patent expiries (factoring in competitive discounts and based on 50% market share) for biosimilar manufacturers is $3.12 billion per year based on current revenues; the equivalent market opportunity in the USA comes to $5.24 billion per year.
To maximise on this opportunity, biosimilar manufacturers need to think seriously about drug delivery. Molecular size and viscosity creates issues around the volume of drug being delivered, as well as potentially causing pain upon administration. We are seeing an increase in self-administration across the globe. As a result, precision dosing, ease of use, comfort, and convenience – all reliant on drug delivery device design – have become key in ensuring patient adherence.
Familiarity and comfort with a particular delivery device also has to be taken into account as it can hinder switching from treatment despite the advice of healthcare professionals.
George I’ons, head of product strategy and insights, Owen Mumford Pharmaceutical Services says: “This latest paper highlights some important issues concerning the key role of design for ‘combination products’ where delivery device and drug are seen as single entity by regulators. This highlights the supporting role of device design in ensuring that drugs, especially newly booming biosimilars, enter the market competitively.”
LR: Why is device design for biosimilars so important in relation to patient adoption and what are the main considerations in drug delivery design for biosimilars compared with other drugs?
GI: The device component is increasingly seen as integral to the therapy as a whole with biologics rather than a secondary consideration, especially since the design of the delivery device may have an impact on patient adherence. Testament to this is the position the FDA has taken by creating a specific category for approval of combination products i.e. the device and drug.
Biologics and biosimilars present specific challenges with respect to formulation development due to the nature of the molecular structure as these types of treatments are typically administered subcutaneously. Typical considerations are the trade-offs between medication volume, viscosity and injection frequency, and delivery time. Higher viscosity formulations may allow less frequent dosing for the patient but increase the complexity of device design. Higher volume injections may mean looking at different options in prefilled syringe and autoinjector design or even considering wearables as alternatives. Injection time, ease of use, lack of pain and needle protection are all key drivers for increased patient acceptance.
It is now widely accepted that the design of a drug delivery device – typically an auto-injector or prefilled syringe device – is a crucial consideration. When switching to a new biosimilar, patients may experience difficulties if they are using a different device that is too unfamiliar. On the other hand, improvements in design and ease of use may be a persuasive factor.
LR: How can drug delivery designers and manufacturers seize upon the opportunities available in this market?
GI: A key element in device design is a thorough and robust human factors (HF) program. The HF process will test user acceptance of a new device and importantly determine the level of risk associated with each step in its use. Results from formative HF studies can provide key insights as to how device design can be modified to create more user-centric product features. Also important for device manufacturers is the ability to be able to offer flexibility in design so that different sizes and configurations of primary containers can be accommodated to allow for varying drug volumes and viscosities. With low volumes typical of biologics the device also needs to ensure that the full dose is delivered to the patient and that the residual volume in the device is as low as possible. Another key consideration is the requirement to ensure that device designs comply with sharps injury prevention regulations and incorporate safety features that prevent needlestick injury and reuse. With many pharma companies creating different doses and formulations of the same molecule, as part of lifecycle management, the ability to have a platform device that can be used for all these variations with minimal design changes is a key factor.
LR: Is it important for device companies to collaborate with drug manufacturers and how easy is this process?
GI: The collaboration between pharma and device manufacturers is essential to developing and bringing a successful combination product to market. This relationship is key throughout the drug development process with horizon scanning for devices often taking place well before initiation of clinical studies. Most large pharma companies employ dedicated device teams who work closely with other internal departments such as formulation chemistry, clinical, sales and marketing as well as creating a close working relationship with the device suppliers. Smaller pharma companies without device teams often need additional technical support and guidance throughout the process so good collaboration - whether large or small - is central to a smooth launch.
LR: You highlight self-administration devices - how important is this market and what are the future opportunities?
GI: We’re seeing self-administration become increasingly important across the world. There are many drivers of this trend: in particular, self-administration helps to ease the burden on hospitals and makes treatment more convenient for patients. This is creating opportunities for manufacturers to favour the production of devices which prioritise ease of use and safety features. There is a growing demand for pre-filled syringes while safety-engineered devices can be seen to dominate the pre-filled market, with three in every four devices offering safety mechanisms. If we look at the market data for safety syringes specifically, an analysis of a range of key research sources reveals that the global pre-filled syringes market was estimated to be worth over $772 million in 2018, rising to some $1.137 billion in 2023: this amounts to a significant growth rate of 8.1%.
LR: Are there any differences between the US and UK markets?
GI: Approval of biosimilars is far more progressed in Europe compared with the US with over 60 approved by the European Medicines Agency to date compared to 25 approved in the US by the FDA. Both US and EU markets have well established regulations in place concerning the requirement for employers to provide safety devices designed to prevent needlestick injury. These regulations apply to the employees regardless of the place of work and so cover acute and home settings. The US FDA has a specific combination product approval process for drug and device combinations. This has yet to be established in Europe and as such in this market the device still requires a CE mark for approval; however the process will change with the introduction of the Medical Device Regulation (Regulation (EU) 2017/745). For Europe the drug is also regulated separately and a marketing authorisation application (MAA) is reviewed and granted by the European Medicines Agency.