More than a thousand biologics are either approved or in clinical development, which pharmaceutical and biotechnology companies are targeting for the treatment of more than 100 acute and chronic diseases. Injectable biologics include monoclonal antibodies, cell therapy, gene therapy, recombinant proteins and vaccines. These high-value therapies, which can each cost more than $1 billion on average to commercialize, represent a significant and growing proportion of the pharmaceutical pipeline. According to research, a pre-clinical biologic is more likely to gain approval than a small molecule compound, and also more likely to successfully complete phase three trials. Biologics are expected to comprise half of the top 100 selling drugs by 2016.
The molecular complexity of biologics means each product can have specific delivery needs including dose volume, drug viscosity, delivery rate and duration that may make ‘off-the-shelf’ commodity devices ill-suited for use. With biologics also having well-defined patient populations, they are instead more suited to platform-based technologies whereby each device can be customized to specific customer, therapy and patient requirements. In many cases, the delivery system can be so integral to the clinical efficacy and performance of the therapy that it is filed for regulatory approval as a drug-device combination product. These factors encourage long-term relationships between drug and device manufacturers that can span the clinical development and commercial lifecycle of an injectable therapy.
Unilife is one of very few companies with the broad selection of injectable drug delivery systems to accommodate the requirements of a broad spectrum of biologic drugs and vaccines. Furthermore, we consider ourselves to be uniquely capable in the design, development, production and supply of platform-based technologies that can be customized to specific customer, therapy or patient requirements.