Introduction
Widespread use of biological medicines has transformed outcomes for many patients with inflammatory conditions such as diabetes, autoimmune diseases, and cancers.[1] These therapies come at a price, however, and as their patents expire, biosimilars are entering the market that are more affordable for healthcare organisations and enable greater patient access to treatment.[1]
Biosimilars should be subject to a robust regulatory framework to gain approval, and show that they demonstrate biosimilarity in terms of structure, biological activity and efficacy, safety, and immunogenicity profile.[1] National regulatory bodies can follow World Health Organization (WHO) recommendations to ensure the quality of biosimilars; while some countries adopt similar practices outlined by the European Medicines Agency (EMA) or the US Food and Drug Administration.[2–4] The aims of this Clinical Forum are to explore the experience of switching patients from biologics to biosimilars in different countries and to provide healthcare professionals with the confidence to help their patients make an informed decision regarding their therapy.
What are the main reasons for switching from a reference biologic to a biosimilar medicine?
Valderílio Azevedo (VA):As a rheumatologist, I have seen biologics revolutionise the management of many chronic inflammatory diseases such as rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
