The molecule-independent device bridging approach (MIDBA): perspective on advancing the evidence base for platform-informed bridging

INTRODUCTION: The need for drug delivery solutions supporting launch of subcutaneously administered biotherapeutics in decentralized care settings has increased interest in abbreviated but scientifically justified clinical device bridging strategies. The recently adopted Qualification Opinion by the CHMP on the Molecule-Independent Device Bridging Approach (MIDBA) established a regulatory framework for clinical bridging from manual injection to an autoinjector for monoclonal antibodies. While the Qualification Opinion applies solely to the regulatory context of the European Medicines Agency and does pertain to other regulatory authorities outside the European Union, it represents an important milestone in the evolution of clinical device bridging. AREAS COVERED: This Expert Opinion examines MIDBA's underlying scientific principles to guide data generation beyond the qualified context of use. The author distinguishes the CHMP-qualified MIDBA from a broader, author-proposed platform-informed device bridging framework, also discussing considerations for large-volume automated injection devices and additional therapeutic modalities. EXPERT OPINION: A basic decision matrix is proposed to identify device bridging scenarios where existing platform evidence may be leveraged. Categorizing molecules based on absorption profile susceptibility to administration conditions and early/peak concentration clinical relevance, this matrix is expected to provide a basis for evaluating future bridging and associated platform data generation while recognizing evidence requirements remain context specific.