Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis

Abstract

ABP-501 is a biosimilar of Adalimumab (Humira) and a tumor necrosis factor-alpha inhibitor that is responsible for inflammatory effects on the body. ABP-501 is equally effective against moderate to severe rheumatoid arthritis (RA) and plaque psoriasis (PsO). In this review, the pharmacokinetics, safety, efficacy, and immunogenicity data of ABP-501 were demonstrated. ABP-501 has been already approved by USFDA and EMA as a treatment option for RA and PsO. The phase-3 study pre-clinical and clinical data affirm ABP-501 was safe and effective against mild to moderate RA and PsO. ABP 501 is also reported for high similarity in structure, function, and pharmacodynamics (PD). This study also focuses on different regulatory issues with biologics and biosimilar such as their development, approval process, criteria that need to be met prior to approval.