Is Adalimumab a Biological Medicine?
Yes, adalimumab (Humira) is definitively a biological medicine—specifically, it is a recombinant human IgG1 monoclonal antibody produced through biotechnology. 1
Classification and Structure
Adalimumab is classified as a biologic therapy and falls within the category of anti-TNF (tumor necrosis factor) monoclonal antibodies. 2
The drug is a fully human monoclonal antibody, distinguishing it from other TNF inhibitors:
- It is produced using recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) expression system 1
- It consists of 1,330 amino acids with a molecular weight of approximately 148 kilodaltons 1
- It contains human-derived heavy and light chain variable regions and human IgG1:κ constant regions, created using phage display technology 1
Mechanism as a Biologic Agent
Adalimumab functions as a biologic by specifically binding to TNF-alpha and blocking its interaction with p55 and p75 cell surface TNF receptors. 1 This targeted molecular mechanism is characteristic of biological medicines, which utilize large protein molecules designed to block specific molecular steps in disease pathogenesis. 2
The British Association of Dermatologists explicitly categorizes adalimumab among "biologic therapies for psoriasis" that "utilize molecules designed to block specific molecular steps important in the pathogenesis of psoriasis." 2
Distinction from Small Molecules
Unlike traditional small molecule drugs or conventional disease-modifying antirheumatic drugs (DMARDs), adalimumab is classified as a biological disease-modifying antirheumatic drug (bDMARD). 2 This classification reflects its production through biotechnology rather than chemical synthesis, and its large molecular structure compared to conventional pharmaceuticals.
Biosimilar Context
The existence of adalimumab biosimilars further confirms its status as a biological medicine, as biosimilars by definition are versions of biological reference products. 2 Five adalimumab biosimilars have been approved by the European Medicines Agency, including ABP 510, SB5, GP2017, FKB327, and MSB11022. 2