Nabeela Zainab*


Biosimilars, based on biopharmaceuticals approved by regulatory agencies that are no longer under patent protection, have efficacy and safety comparable to their reference products, and are a new therapeutic option to treat inflammatory rheumatic diseases (IRD). Before they are approved, biosimilars must undergo a rigorous development process to establish biosimilarity to the reference biological product. After approval, biosimilars must comply with good pharmacological practices for biological drugs. CT-P13, based on infliximab, was the first biosimilar approved for the treatment of inflammatory diseases; however, some countries did not allow extrapolation of indications to all eight diseases for which the reference drug infliximab is approved. Several biosimilar disease-modifying antirheumatic drugs (bsDMARDs) based on the tumour necrosis factor inhibitors adalimumab, etanercept and infliximab have been approved for use in patients with rheumatic diseases. Substantial cost savings can be made if biological-naive patients begin treatment with bsDMARDs, and patients receiving original biological DMARDs (bDMARDs) are switched to bsDMARDs. The current review article addresses the importance of biosimilar medicines in the treatment of IRD, as well as their innovative development and regulatory pathways, clinical evidence of similarity. It discusses the biosimilars already approved in the past 7 years. With an emphasis on European Union and US markets, it gives an overview of challenges that may undermine their widespread use and success including the definition of strategies for adequate pharmacovigilance to monitor biosimilars after marketing approval.

Keywords: biosimilar, biologics, rheumatology, rheumatic disease, development, infliximab, etanercept, adalimumab, interchangeability, switch, extrapolation, budget impact analysis.

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