Biosimilars in Pediatric Rheumatology

Dilara ÜNALa , Emil ALİYEVa , Yelda BİLGİNERa

aHacettepe University Faculty of Medicine, Department of Pediatric Rheumatology, Ankara, Türkiye

ABSTRACT
Targeted biological therapies have become a significant component of treating rheumatic diseases since the introduction of the first tumor necrosis factor (TNF) inhibitor in 1998. The high cost of these products limits many people’s access to them. Introducing biosimilar medications in 2013 may have provided more widespread access to these ”high-cost” medicines. A biosimilar is a legal copy of the ”reference product” or ”bio-originator” that is no longer protected by a patent that has undergone attentive analytical and clinical evaluation in comparison to its reference product and been approved by a regulatory agency according to a predetermined pathway for biosimilars, to ensure that the biosimilar and its biooriginator have equivalent efficacy and highly similar structure and that they have ”no clinically meaningful differences” in pharmacokinetics, efficacy, or safety. A biosimilar must demonstrate ”sameness” as the reference product by demonstrating analytical, pharmacokinetic, and clinical equivalence to the reference product in a series of comparative studies. Biosimilars of tumor necrosis factor inhibitors and rituximab have been approved by regulatory agencies to treat rheumatoid arthritis and other inflammatory diseases and are commercially available in many countries. Other biosimilars of adalimumab, etanercept, infliximab, and rituximab and biosimilars of abatacept, golimumab, and tocilizumab are in development to treat rheumatologic and other inflammatory diseases. Studies on biosimilars in the pediatric age group are limited. There are only studies on adalimumab and etanercept in the pediatric age group. As a result of the studies conducted to date, using biosimilars in pediatric rheumatology is safe and cost-effective. In addition, they have similar and tolerable side effects to generic drugs and can be used by patients. Real-time studies with longer duration and more extensive disease and patient populations are needed for initiation and switching to biosimilar therapy.
Keywords: Biological agents; biosimilars; pediatric rheumatology

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