Biosimilars of Adalimumab: A Review

Abstract

Before December 2002 treatment of Rheumatoid Arthritis included NSAIDS, Analgesic, Steroids and Immunosuppressive medications. After the invention of the therapeutic monoclonal antibodies for the treatment of Rheumatoid Arthritis, healthcare system has made remarkable changes in efficiency and efficacy for treatment. On 31st December 2002 the US Food and Drug Administration approved the first monoclonal antibody; Adalimumab under name Humira®. Abbvie being the originator has been granted the patent to market the product until 2024, but several companies across the globe have been doing research for biosimilar of Adalimumab. Biosimilar are medical products derived from natural sources or produced recombinantly in cells. Till today FDA has approved five biosimilars of Adalimumab and will be marketed by after 2024. Mabura from Hetero drugs, Adfrar from Torrent Pharmaceuticals and Exemptia from Zydus Cadila Healthcare has been approved for marketing the product in India. All the biosimilar has to be iden􀁗ical 􀁚i􀁗h 􀁒􀁕iginal 􀁓􀁕􀁒d􀁘c􀁗 Abb􀁙ie􀂶􀁖 H􀁘mi􀁕a􀂊. Se􀁙e􀁕al attributes can be used to compare the analytical and functional similarity of the respective biosimilar to that of Adalimumab (Humira®). In this project we will discuss the list of approved and under development biosimilars of Adalimumab and their analytical and functional similarity with original Humira®