Romanian Society of Pharmaceutical Sciences

« Back to Farmacia Journal 3/2022



1Faculty of Pharmacy, Middle East University, Amman, Jordan
2Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan

Download Full Article PDF

The development of monoclonal antibodies has revolutionized the pharmaceutical industry by offering clinicians a wide range of therapeutic agents for the treatment of a variety of disorders. Unlike small molecule drugs, monoclonal antibodies are large and complex molecules that are generated using genetically engineered living cells. Due to the high complexity of this class of molecules, producing exact copies is impossible and with several originator biological agents losing their patents in recent years, several pharmaceutical manufacturers are pursuing the development of generic biopharmaceuticals or what is known as “biosimilars” as alternative biological therapeutics. Adalimumab represents one of the most prescribed monoclonal antibodies in clinical practice. With the originator adalimumab losing its patency in 2018, several manufacturers are pursuing the development of adalimumab biosimilars with varying degrees of quality and thus exposing different markets to biosimilars of inferior quality or what is known as intended copies. These molecules could pose a major harm to patients as a result of the unexpected immunogenicity or lack of efficacy that results from their lack of similarity to the originator biologic. The aim of this review is to provide technical guidance for the pharmaceutical personnel working in research and development of adalimumab biosimilars in addition to regulatory assessors’ worldwide reviewing biosimilars dossiers within public health authorities. The review article will detail all the development stages needed for the development of adalimumab biosimilars within the comparability exercise that is required by manufacturers to provide regulatory agencies with strong evidence of adalimumab biosimilarity.