BD announces first pharma-sponsored clinical trial using BD Libertas wearable injector technology for biologic drugs

BD (Becton, Dickinson and Company), a medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas Wearable Injector for subcutaneous delivery of complex biologics. 

The selection of BD Libertas Wearable Injector for this pharma-sponsored trial follows successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, including a device clinical study demonstrating excellent performance with 100 per cent of study participants stating they would likely use the BD Libertas Wearable Injector if prescribed(i),(ii).

The pharma-sponsored combination product clinical trial represents a significant advancement in accelerating innovation in drug-device combination products that provide greater flexibility for patients, including potential conversion from infused medications that require patients to travel to a hospital or clinic to more convenient patient care in various settings, including self-injection at home.  

The BD Libertas Wearable Injector is a prefilled, patient ready-to-use drug delivery system (iii) designed to enable delivery of complex biologics via subcutaneous injection. The biologics market is expected to grow to more than $670 billion(iv) by 2030, and for pharmaceutical companies developing these complex drugs, the BD Libertas Wearable Injector offers a customisable, patient-centric solution. The BD Libertas Wearable Injector:

• Supports delivery of high-viscosity biologics (up to 50 centipoise), enabling a wide range of subcutaneous therapies
• Is offered in 2 to 5 mL and 5 to 10 mL configurations, providing flexibility for diverse therapeutic requirements
• Features a fully mechanical, patient ready-to-use design with a simple “peel, stick and click” mechanism, requiring no end-user filling or assembly(iii)

BD’s ongoing validations of fill-finish and final assembly processes with multiple Contract Manufacturing Organizations (CMOs) enable the company to support pharmaceutical partners from development through commercial-scale production. 

References

(i) Early feasibility clinical study of investigational BD Libertas™ Wearable Injector (WI) evaluated 5ml, non- Newtonian ~8cP subcutaneous placebo injections in 52 healthy adult subjects for functionality, tissue effects, subject tolerability (100mm Visual Analog Scale (VAS)) and acceptability (questionnaires with 5-point Likert or yes /no responses). Tissue effects were measured from WI removal post-injection through 24 hours with calipers (wheals) or graded on a 5-point scale (erythema, bleeding) from 0-none to 4-severe, significant, respectively. Where tissue effects were observed, the majority (>50%) were resolved within 60 minutes and all within 24 hours. Subject pain (100mm VAS) peaked mid-injection (mean 9.1mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0 .4mm, SD 2.6). Subjects found acceptable (Likert agree + strongly agree or yes responses) their peak pain (≥90.2%), injection site appearance (≥92.2% ).
(ii) Woodley, W. D. et al. Clinical Evaluation of an Investigational 5ml Wearable Injector in Healthy Human Subjects. Clin Transl Sci. 2021 May;14(3):859-869. doi.org/10.1111/cts.12946.
(iii) Pharma filled and assembled
(iv) Mordor Intelligence (2025). Biologics Market Size – Industry Report on Share, Growth Trends & Forecasts Analysis (2025 – 2030). https://www.mordorintelligence.com/industry-reports/biologics-market