- Author(s):
- Organization(s):
BBSG Pharm Associates
Biological therapeutics have reshaped modern medicine by offering high specificity, potency and durable efficacy across a broad spectrum of diseases, including cancer, inflammatory disorders and rare genetic conditions. Despite these transformative advances, inhaled biologics intended for local pulmonary action have experienced a notable and persistent quiescence in market introductions, particularly when contrasted with the rapid expansion and commercial success of systemically administered biologics.
This article examines the historical evolution of inhaled biologics alongside the intrinsic pulmonary barriers, formulation and device challenges, and regulatory constraints that have collectively perpetuated this quiescence. By integrating evidence from historical development programs, clinical outcomes and contemporary research advances, this article identifies the key hurdles limiting progress and highlights emerging scientific and regulatory pathways that may enable renewed momentum for inhaled biologic therapies.
June 2026, Volume 20(3), pages 13-22