Chronic clinical conditions are considered to be among the leading causes of death and disability globally. Typically, individuals are required to medicate on a daily, weekly, and/or monthly basis. In addition to the cost of medication, patients are also burdened with a deteriorating quality of life. Now more than ever, patients are taking a more active role in their health and want to make treatment a smaller part of their life. The development and commercialization of self-administrable medicinal products outside a clinic, hospital or healthcare provider environment, is an attractive alternative not only for healthcare expenditure but also patients because of the inherent flexibility and desire to reduce clinic visits. As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient friendly drug delivery systems. Over the past 5 years, significant improvements have been made to address dose volumes and treatment options, such as monoclonal antibody-based therapies. These treatments often have viscous, highly concentrated drug formulations that require higher doses and delivery volumes that are typically outside the range of standard syringe capabilities. Novel drug delivery technologies are being introduced, specifically, large volume, on-body delivery systems. The novelty of these solutions has increased the complexity of regulations and particularly how to navigate the regulations from a global perspective.
Currently, the majority of large volume wearable injectors are primarily present in North America and Europe, within which the principal global regulatory frameworks are led by, or based on, the United States and European regulations. These large-volume on-body delivery systems are typically co-packaged with pre-filled drug cartridges i.e., co-packaged combination products. However, the pathway to approval differs between the US and Europe which can lead to diverse, complex regulatory strategies when developing a product that must meet both regulatory frameworks.