FDA approved PFS-based autoinjectors: evolution, market trends, and development challenges

INTRODUCTION: With the rapid expansion of the biopharmaceutical industry, particularly in chronic disease treatment and immunotherapies, self-injection has emerged as a preferred method for patient-administered therapies. AREAS COVERED: Prefilled syringe (PFS)-based autoinjectors have become the most widely adopted self-injection devices due to their convenience, efficiency, and acceptance by patients, caregivers, and healthcare providers. Despite the growing interest and increasing FDA approvals for autoinjector products, comprehensive reviews focusing specifically on disposable PFS-based autoinjectors remain limited. This review addresses that gap by systematically analyzing based on data retrieved from the U.S. Food and Drug Administration's official website, including FDA-approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) since 1980. EXPERT OPINION: Furthermore, the technical challenges in incorporating injectable formulations into spring-driven autoinjector systems are discussed. This review aims to facilitate the development of safer, more efficient autoinjector platforms that enhance user experience and treatment adherence.