The Impact of Waiving Confirmatory Efficacy Studies on Biosimilar Development Costs and Timelines: A Comparative Analysis of Adalimumab Biosimilars

Abstract

The emergence of biosimilars has transformed healthcare by offering cost-effective alternatives to biologics and broadening treatment choices for various conditions, including diabetes, cancer, and growth disorders, demonstrating comparable efficacy and safety profiles to their reference products. Confirmatory efficacy studies (CES), a requirement mandated by regulatory authorities, are expensive and time-consuming without providing added value. To facilitate the availability of these essential treatments, this study sheds light on the sufficiency of quality and non-clinical aspects in demonstrating biosimilarity, and the implications of waiving CES requirement on the development cost and timeline. Ten Adalimumab biosimilars were assessed for major objections from EMA on the analytical similarity assessment, the number of clinical trials conducted for type I and type III studies, the sample size of each study, phase III studies duration, which reflect CES, and the prices compared to their reference product Humira. Analysed data showed that the use of state-of-the-art analytical methods confirmed high similarity with Humira, with only three biosimilars receiving major objections on their applications, which were resolved using nonclinical studies and deemed unrelative to the safety and efficacy, confirming CES’s lack of value. The median duration for phase III confirmatory efficacy studies was 52 weeks, and the estimated cost for conducting those studies ranged between $20,517,887 and $52,039,597. Adalimumab biosimilars offer up to an 81% price reduction, highlighting the importance of facilitating biosimilars’ availability, the need for eliminating CES and its implication on the development cost and timeline, and the ultimate benefit for the healthcare system.