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Biological drugs (biologic response modifiers) are a class of drugs that specifically targets cellular subsets (T or B cells), adhesion molecules or a variety of proinflammatory cytokines (eg, tumour necrosis factor α, interleukins 1, 6, 17, etc).1 The introduction of biological drugs has revolutionised the treatment of chronic rheumatological diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic vasculitis and many others. They have also changed the treatment paradigm of other diseases, such as psoriasis, pemphigus, inflammatory bowel and eye diseases, lymphoma and other malignant diseases. Biologics have shown superior/similar efficacy and safety compared with traditional disease modifying drugs, and have reduced the need for non-steroidal anti-inflammatory drugs and corticosteroids. Disease remission and inhibition of radiographic progression have become realistic achievable goals with the use of biologics, and they have been shown to improve quality of life, and reduce morbidity and mortality.2 However, one of the major disadvantages of these drugs has been their prohibitive cost. This has made the quest to look for cheaper drugs very important. The introduction of biosimilars, which cost about 20–30% less than the originators, has to some extent reduced the cost burden of treating chronic rheumatological diseases.
The definition and terminology for biosimilars have been discussed by various countries/agencies. The US Food and Drug Administration (FDA) has defined a biosimilar as a ‘biological product that is highly similar to the US licensed reference product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product’ (as per Biologics Price Competition and Innovation Act 2009).3 The European Medicines Agency (EMA) has defined a biosimilar ‘as a biological medicinal product that contains a version of the active substance of an already authorised …
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