Learning Tracks

Autoinjector clinical bridging studies evaluate whether a biosimilar delivered through an autoinjector device can be considered equivalent to a reference product. This session will explore the latest progress and thinking from FDA on autoinjector clinical bridging studies while also providing industry’s view on the challenges they face with bringing their autoinjector to patients. While this session is intended to focus on biosimilars, some of the concepts may be applicable to generics.

Participants:
Cristina Ausin, PhD 
Scientific Reviewer, OTBB, OND, CDER, FDA

Navayath Shobana
Senior Director Regulatory Affairs, Fresenius Kabi

Maria Burkholder, MHA
Senior Director, Regulatory Affairs, Teva Pharmaceuticals

Moderator: Elisabeth Kapeller
Portfolio Head Regulatory Devices, Sandoz