Background Biosimilars are innovative therapeutic drugs which offer a cheaper alternation for biological which used for management of chronic rheumatic diseases. The aim of this review is to go through the written data to introduce biosimilars in our countries.
Methods Biosimilars are considered as an opportunity for rheumatology patients who are on traditionally expensive biological.
Some countries in (MENA) region Middle East and North Africa are unable to adjust their healthcare expenditure to provide biologic therapies. 71% rheumatologists from MENA countries at meeting were agreed with European League Against Rheumatism (EULAR) recommendations for introduction of biologic therapy.
Egypt has already established their own regulatory frameworks for biosimilar approval in 2013. Interest in biosimilar researches in MENA region continues grow to introduce price competition, transitioning from biological to biosimilar for rheumatoid, ankylosing, psoriasis and reduce the expenditure of healthcare without any differences in health outcomes which is important from a social perspective.
Results In 2013 the European Medicines Agency (EMA) has approved biosimilar for treatment of inflammatory disease. Adalimumab biosimilars will be available in the European market at the end of 2018. Switching to rituximab biosimilars in rheumatic conditions is still restricted to small sized studies with limited reporting of efficacy and safety outcomes. Depend on evidence several biosimilars approved by the EMA for adalimumab (BI 695501, SB5, and ABP 501), infliximab (SB2, CT-P13, and infliximab-qbtx), etanercept (GP2015 and SB4) and rituximab (CT-P10 and GP2013). The duration of treatment were detected in many trials Published data in EMA Public Assessment Reports (EPAR), PubMed and European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR).
Conclusions Switching to biosimilars in the treatment of inflammatory rheumatic conditions continue as great deal of attention give promise of significant cost saving. Biosimilars could be a good option as first line therapy based on available data but clinical studies are still not sufficient.
Funding Source(s): None
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.