Biological medicines were developed more than 30 years ago and have steadily increased in significance in treating serious conditions. The first biological medicine approved for therapeutic use was biosynthetic insulin (called Humulin®) to treat diabetes, in 1982. Biosimilar medicines were introduced in Europe in 2006. Their use has steadily increased over time, and they are used to treat more conditions. The approval and use of biosimilar medicines has steadily grown since their introduction in 2006. Biosimilar medicines are available in more than 60 countries around the world. Biosimilar medicines are currently used in five main clinical areas: The European Union was the first region to set up a regulatory framework for the approval of biosimilar medicines, and its initial regulatory guidelines were published in 2005. Since then, a number of biosimilar medicines have been approved and used by patients in the European Union. In 2010, the World Health Organization published their Guidelines on evaluation of similar biotherapeutic products. In the rest of the world, including in Australia, the European Union regulatory framework and World Health Organization guidelines have been the models for biosimilar medicine regulation. The use of biosimilar medicines over the next 10–20 years is likely to grow across the world, as the patents on many reference biological medicines expire. Key points
Australian Biosimilar Timeline