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Introduction
Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the therapeutic management of inflammatory rheumatic diseases with dramatic clinical improvement and reduction in systemic inflammation in arthritis on the one hand, and slower joint degradation (in rheumatoid arthritis (RA) and psoriatic arthritis) on the other hand. These drugs are able to induce clinical remission and in fine strongly improve patient quality of life. Due to their high levels of efficacy, bDMARDs are widely used in chronic arthritic conditions with a strong increase in treatment costs. The recent expiry of patents for the first bDMARDs such as tumour necrosis factor (TNF) inhibitors has led to developments in biosimilar (bs) DMARDs.1 2 The European Medicines Agency (EMA) has approved bsDMARDs of infliximab (with CT-P13 produced by Celltrion and commercialised as Remsima or Inflectra, and SB2 produced by Samsung Bioepis and commercialised as Flixabi) and SB4, a bsDMARD of etanercept (Benepali by Samsung Bioepis). With these new agents, the reduction in cost treatment in Europe between now and 2020 was estimated at between €11 and €33 billion.3
Since bsDMARDs were introduced to the market, many questions emerged about their use in routine practice.4 5 Indeed, the issue of changing from biological originator (bo) DMARDs to its/their bsDMARDs is open to debate despite a systematic switch for all patients receiving boDMARDs in some countries. Here, we review the different concerns that may be raised when switching from a reference biopharmaceutical to its/their bsDMARDs and consider the pros and cons of switching in clinical practice. We focus the discussion on TNF inhibitors in rheumatic inflammatory disorders.
Development of a biosimilar: the challenges
The development of bsDMARDs had to follow rigorous and comprehensive comparability specifications in order to assume and prove biosimilarity to its boDMARD according to official medicine agency guidelines. Specifically, a bsDMARD had to demonstrate similar characteristics in terms of …