Force Degradation Comparative Study on Biosimilar Adalimumab and Humira

Abstract

CinnoRA® has been developed by CinnaGen Co., as abiosimilar adalimumab of originatHUMIRA®. Biosimilarsare defined as “similar” or “highly similar” to the referencemedicinal products(originator products) which arelarge molecules with an inherent physicochemical complexity.Such complex molecules with a variety of functionalgroups are susceptible to instability through differentdegradation pathways, it is a matter of great concernas it affects the quality, safety and efficacy of the drugproduct. So force degradation or stress stability studies areexpected to be part of the demonstration of similarity ofa biosimilar to reference product as well as orthogonalanalytical techniques to characterize the physicochemicaland functional properties of biosimilar in comparison withoriginator. A force degradation protocol designed to exposesample to oxidative, acid and base hydrolysis, thermal,photolysis and mechanical stress conditions. Sampleswere tested in defined time points by validated analyticalmethod to detect aggregated forms by size exclusionchromatography, acidic and basic charged variants by ionexchange chromatography and TNF-α neutralizing activityof adalimumab by invitro bioassay. The results were analyzedby Minitab statistical software and the results demonstratethe comparable degradation pathway betweenbiosimilar and reference product in all conditions.