Journal of Chromatography & Separation Techniques
Open Access

The end of phase 3 clinical trials in biosimilars development

Joint Event on 9^th World Congress on Chromatography & 24^th International meet on Pharmaceutical Biotechnology

May 13-14, 2019 | Paris, France

Francois-Xavier Frapaise

FX Frapaise Pharma Consulting, France

Posters & Accepted Abstracts: J Chromatogr Sep Tech

Abstract :

Most patients still have limited or no access to life-changing therapeutic proteins in the treatment of their cancer or autoimmune disorders. The current clinical development model of biosimilars is expensive, and in most cases, large phase 3 trials do not provide meaningful information on the clinical equivalence of biosimilars and reference compounds. At the same time, the development of state-of-the-art orthogonal analytical methods has enabled a better understanding of the structure and structure�??function relationship of these biotherapeutics. Hence, we suggest here that a solid chemistry, manufacturing, and controls (CMC) package and meaningful phase 1 studies will leave limited uncertainty on bio similarity, which can be addressed, if needed, by post-approval, long-term follow-up studies (post-approval studies, pharmacovigilance, real world evidence data and registries, and possibly new post-approval models to be developed). We believe that this new approach may be more appropriate than 600- to 1000-patient, phase 3 trials in assessing biosimilarity and therapeutic equivalence. Obviously, there will probably never be a �??one size fits all�?� development model, and an individualized, risk-based approach to biosimilar development will always have to be considered and discussed early with regulators.