The interchangeability of original tumor necrosis factor- α inhibitors and biosimilars in rheumatology: experience in replacing original infliximab with Flammagis for ankylosing spondylitis

Yu V Muravyev,V V Lebedeva,A S Starkova,D G Rumyantseva,M M Urumova,Sh Erdes

doi:10.14412/1996-7012-2020-2-104-109

Abstract

The paper discusses prospects for prescribing tumor necrosis factor-α (TNF-α) inhibitor biosimilars, their interchangeability with original drugs for inflammatory joint diseases. It describes clinical cases when original infliximab is replaced with its biosimilar Flammagis for ankylosing spondylitis. The authors emphasize that it is difficult to predict the interchangeability of original TNF-α inhibitors and biosimilars in rheumatology, and this is confirmed by the above clinical cases. They also indicate that the optimal use of biosimilars requires a constant cooperation of rheumatologists, pharmacologists, and regulatory authorities, which is aimed at protecting the rights of a patient in order to ensure safe, effective and high-quality care. It is concluded that it is advisable to conduct further investigations to develop a special pharmacovigilance system in this area.

Highlights

The interchangeability of original tumor necrosis factor-α inhibitors and biosimilars in rheumatology: experience in replacing original infliximab with Flammagis for ankylosing spondylitis Muravyev Yu.V., Lebedeva V.V., Starkova A.S., Rumyantseva D.G., Urumova M.M., Erdes Sh
The paper discusses prospects for prescribing tumor necrosis factor-α (TNF-α) inhibitor biosimilars, their interchangeability with original drugs for inflammatory joint diseases. It describes clinical cases when original infliximab is replaced with its biosimilar Flammagis for ankylosing spondylitis
The authors emphasize that it is difficult to predict the interchangeability of original TNF-α inhibitors and biosimilars in rheumatology, and this is confirmed by the above clinical cases

Summary

Introduction

The interchangeability of original tumor necrosis factor-α inhibitors and biosimilars in rheumatology: experience in replacing original infliximab with Flammagis for ankylosing spondylitis Muravyev Yu.V., Lebedeva V.V., Starkova A.S., Rumyantseva D.G., Urumova M.M., Erdes Sh. При обследовании сохранялся артрит коленных, голеностопных суставов, появились выраженная боль воспалительного ритма в позвоночнике и высокая лабораторная активность: СОЭ 36 мм/ч, СРБ 4+. (через 6 нед после последней инфузии) вновь зафиксировано повышение лабораторных показателей активности заболевания, возобновление боли в суставах и позвоночнике, в связи с чем доза МТ была увеличена до 15 мг/нед, проведено 7-е введение

Results

Conclusion