For biosimilar manufacturers, the market potential is significant, especially for those that are first to market
Biosimilars represent a new wave of generic market expansion. The US Food and Drug Administration (FDA) stipulates that after a drug comes off patent, generics manufacturers can begin filing an Abbreviated New Drug Application (ANDA).
The first company to do so receives a 180-day period of market exclusivity. This is quite an advantage: for approximately 6 months, their offering is the only generic option available.
However, biosimilars — like biologics — can present significant challenges regarding both containment and delivery. Unlike biologics, the development of a customised delivery technology is unreasonable, if not nearly impossible, when working in an expedited timeline. Because of this, biosimilar drug makers often rely on “off-the-shelf” systems that will still, most likely, require device adaptation based on dose volume, formulation viscosity and even the selected needle shield.
However, by partnering with a containment and delivery partner early in the drug development process, biosimilar manufacturers can more efficiently clear the path to be first to file while ensuring the safe, effective delivery of their therapy.
Like biologics, biosimilars are designed to be delivered to the patient using self-administration technology. Biologic drug makers and delivery system manufacturers have collaborated in recent years to create customised, innovative systems that can be safely and easily used by patients. However, companies developing biosimilars do not often have that luxury.
Because biologics are very complex, they are more difficult to replicate than small molecule drugs, leaving few resources — both from a financial and timing perspective — to develop a delivery system that’s specific to the drug in a timeline that could allow market exclusivity. Because of this, biosimilar manufacturers must turn to ready-made delivery systems.
However, being readily available is not the only requirement. These delivery systems must also be capable of safely containing sensitive therapies, which can potentially involve adverse interaction issues with primary containers. Additionally, the delivery system must be patient-centric, while emphasising quality and the versatility to handle various dose volumes and formulation viscosities, and also avoiding time-consuming development projects.
Both the drug and its packaging must meet the strict quality standards set by regulatory agencies. To that end, Quality by Design (QbD) has become a non-negotiable aspect of drug delivery technology development.
By applying a data-driven QbD approach to the design and development of drug delivery systems, packaging manufacturers can gain a thorough understanding of both the product and the process. This, in turn, provides multiple benefits for end-users and manufacturers, including ensuring that a delivery system consistently functions as needed and expected.
A number of biosimilar therapies that will be coming off patent in the coming years treat conditions that can compromise a patient’s dexterity and strength, such as rheumatoid arthritis, multiple sclerosis and Parkinson’s disease. The system used to administer a therapy can greatly affect a patient’s emotional attitude and motivation to sustain treatment, and could ultimately affect the drug’s impact and success in the marketplace.
Therefore, biosimilar manufacturers should look for drug delivery systems backed by data that lend credibility and reassurance that the system not only performs as expected, but is also truly intuitive and easy for patients to use.
Although ensuring quality and patient centricity will always be paramount, utilising delivery systems that are relevant for future applications is incredibly important as well. For example, leveraging self-injection technology that can adapt across dose volumes for a single drug or portfolios of drugs — regardless of fill volume or viscosity — can help to minimise the time to validate and go to market.
Additionally, addressing the challenge of adherence continues to be a focus area for the pharmaceutical industry. As self-administration outside the healthcare system continues to rise, manufacturers are increasingly looking toward “connected” drug delivery systems to engage patients, encourage them to take a more active role in their self-care and facilitate communication with their provider about adherence to prescribed therapies.
For biosimilar manufacturers, there are many considerations when pursuing that 180-day window of exclusivity.
A delivery system can be available in an expedited timeframe without sacrificing quality, patient centricity and adaptability. By collaborating with a forward-thinking drug containment and delivery partner, biosimilar manufacturers can ensure that they are bringing their product to market safely, efficiently and with the end-user as the priority.