Device Differences Matter: Why Addressing Negative Transfer Is Critical to Biosimilar Success
As biosimilar and interchangeable biologic therapies continue to expand patient access to treatment, the industry has an opportunity to focus on more than affordability and availability. The patient experience must remain a priority, particularly as new delivery devices enter the market.
The FDA’s recently released draft guidance on delivery devices and container closure systems for biosimilar and interchangeable products highlights an important consideration: differences in delivery systems should not compromise safety or effectiveness.
While these differences may appear minor from a product development perspective, they can create significant challenges for patients. One of the most important, and often overlooked, risks is a phenomenon known as negative transfer.
Understanding Negative Transfer
Negative transfer occurs when a patient applies knowledge, behaviors, or expectations from one device to another device that functions differently.
For example, a patient who has spent months or years using one autoinjector may naturally assume that a new biosimilar device operates the same way. The patient may expect the same activation mechanism, injection duration, hold time, feedback cues, or sequence of steps. When those assumptions are incorrect, the result can be confusion, use errors, frustration, and reduced confidence.
Ironically, patients with prior experience may sometimes be at greater risk than first-time users because they believe they already know how the new device works.
As biosimilar adoption increases and patients transition between products, addressing negative transfer must become a central consideration for manufacturers, healthcare providers, and patient support teams.
Device Differences Can Create Real-World Consequences
Many biosimilar products are designed to provide comparable therapeutic outcomes, but the patient experience is not always identical.
Differences in device ergonomics, activation methods, injection times, audible or visual feedback, and instructions for use can introduce unexpected challenges. Even seemingly small variations can affect a patient’s ability to administer therapy correctly and confidently.
The consequences extend beyond a single injection event.
Research suggests that approximately 40% of patients receive no self-injection training prior to treatment initiation.¹ When patients are asked to navigate a new device without sufficient guidance, the potential for negative transfer increases significantly. Patients may unknowingly apply habits learned from a previous device to a new injection process, increasing the risk of confusion, use errors, and hesitation.
This challenge becomes even more important during the critical early stages of therapy. Research shows that early experiences with a self-injection device can have a lasting impact on patient confidence, adherence, and persistence. Patients who begin treatment without adequate preparation may be more likely to delay therapy initiation, make administration errors, seek outside guidance, or discontinue treatment prematurely.
For manufacturers, this represents more than a patient engagement issue. Poor patient readiness can create measurable impacts on therapy adoption, persistence, patient lifetime value, and overall program performance. When patients lack confidence in their ability to use a device correctly, the value of an otherwise effective therapy may never be fully realized.
Confidence Drives Adherence
As healthcare continues to shift from clinical environments into the home, patients are increasingly responsible for administering complex therapies independently.
Success depends on more than device availability. Patients must understand how to use the product correctly and feel confident doing so.
Poor patient readiness often leads to poor outcomes. Patients who are unsure how to use a device may delay treatment, make administration errors, discontinue therapy, or require additional support. These challenges create leakage throughout the patient journey and can limit the real-world impact of otherwise effective therapies.
Conversely, patients who feel prepared are more likely to initiate therapy successfully, remain engaged, and adhere to treatment over time.
Confidence drives adherence.
The key question for manufacturers is no longer whether patients can learn to use a device. The question is whether organizations are doing enough to prepare them for success before the first dose is ever administered.
Education Must Go Beyond Instructions for Use
Traditional instructions for use remain important, but they are rarely sufficient on their own to overcome the challenges associated with device transitions and negative transfer.
Patients often benefit from multiple forms of learning, including visual demonstrations, hands-on practice, digital support tools, onboarding programs, and reinforcement throughout the therapy journey.
Effective education should help patients:
- Understand how their specific device functions
- Identify differences from previous devices
- Avoid assumptions that may lead to use errors
- Build familiarity before administering therapy
- Develop confidence through practice and repetition
When education strategies explicitly account for negative transfer, patients are better prepared to recognize and adapt to device differences before those differences impact adherence.
Human Factors Research Provides the Foundation
Addressing negative transfer begins long before commercialization.
Human factors and user experience research help organizations understand where patients may struggle, what assumptions they bring to the experience, and how device differences may affect use behavior.
These insights can then be applied to product design, training materials, onboarding programs, healthcare provider education, and patient support initiatives.
By identifying potential areas of confusion early, organizations can create more effective educational interventions that reduce risk and improve patient preparedness.
Rather than treating training as a final step, leading organizations are integrating patient education strategies throughout the development lifecycle.
Turning Access Into Outcomes
The continued growth of biosimilars represents an important advancement for healthcare. Increased competition can expand access to life-changing therapies and create greater choice for patients and providers.
However, access alone does not guarantee success.
Patients must be prepared to navigate device differences confidently and safely, particularly in an environment where transitions between products may become increasingly common.
By addressing negative transfer through human factors research, training devices, onboarding programs, and patient education initiatives, manufacturers can help ensure that greater access translates into better outcomes.
Because in the end, successful therapy adoption depends on more than getting a product into a patient’s hands.
It depends on ensuring they know exactly how to use it, and feel confident doing so from the very first dose.
About Noble
Noble, an Aptar Pharma company, helps pharmaceutical and biotechnology organizations address patient readiness challenges through human factors research, training device development, patient onboarding solutions, and educational programs designed to support confident product use, reduce the risk of negative transfer, and improve long-term adherence.
References
- Hawthorne J, Katsaros D, Rinaldi A, et al. The current paradigm for biologic initiation: a confirmatory quantitative analysis of self-injection training practices. Expert Opinion on Drug Delivery. 2022;19(6):733-742. Available at: View publication.