How have biosimilar medicines been used around the world?

Page last updated: 23 March 2017

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.

Australian Biosimilar Timeline

This graphic outlines the timeline for biosimilar medicines and regulation in Australia. The Therapeutic Goods Administration (TGA) first adopted the European Medicines Agency guidelines on biosimilar medicines in August 2008. From 2010 to 2013, 7 biosimilar medicines were approved for use. In July 2013, the TGA evaluation of biosimilars was published, and 4 more biosimilar medicines were approved from 2013 to 2015. In December 2015, the TGA updated the regulation of biosimilar medicines, and 2 more medicines were approved in 2016. Seven of these medicines (Novicrit, Nivestim, Omnitrope, Tevagrastim, Zarzio, Inflectra and Bemfola) are also listed on the PBS.

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:

  • insulin is used to treat diabetes
  • human growth hormone, also known as somatropin, is used to treat children’s growth disorders and adult growth hormone deficiency
  • epoetin controls red blood cell production and is commonly used in kidney disease
  • filgrastim is used in certain cancer patients to accelerate recovery from chemotherapy
  • infliximab (an anti–tumour necrosis factor therapy) is used to treat autoimmune diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease.

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.

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