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Biologic therapies have entirely revolutionized the treatment of many debilitating, life‐changing chronic autoimmune diseases like rheumatic arthritis and plaque psoriasis as well as life‐threatening cancers for which no viable treatment option has existed previously. They also play a critical therapeutic role in many endocrine disorders and neurodegenerative conditions. Biologics are the fastest growing sector of the drug market¹ and are also the most expensive therapies. As a result, “highly similar” versions of innovator biologics, biosimilars have been introduced to provide cost‐effective biologic treatments.

The first innovator biologic was introduced ~40 years ago, and the first biosimilar was introduced in the European Union (EU) and United States (USA) in 2006 and 2015, respectively. Currently, there are over 300 biologics registered worldwide and the EU has over 60 approved biosimilars. In the United States, biosimilars are an emerging market, with 19 approved biosimilars. Biosimilar market access comparison between the United States and EU has shown that market access in the United States is less favorable. This is due to many factors including lack of incentives to prescribe biosimilars in the United States and small price discounts of biosimilars compared to innovator biologics.²

In many countries, including Australia and emerging pharmaceutical markets like Brazil, biosimilar use is actively encouraged as governments attempt to contain the costs of expensive innovator biologics. Assuming discounts on off‐patent innovator biologics and biosimilars of ~50%, it is predicted that by 2020 there will be annual savings of over €8–10 billion in the EU.³

Biologics are complex proteins or protein‐like molecules produced using biotechnology techniques in living cells. Their structural, functional, and manufacturing processes lead to clinical concerns/controversy about their efficacy and safety, including the potential for treatment failure and severe immunogenicity reactions. Pharmacists, doctors, and other health professionals, therefore, need to be fully conversant with all aspects of their clinical utility.