How have biosimilar medicines been used around the world?

Page last updated: 07/12/2016

The first biological medicine approved for therapeutic use in the United States was biosynthetic insulin, for the treatment of diabetes. It was developed by Genentech and licensed to Eli Lilly & Company who manufactured and marketed it under the brand name Humulin®, starting in 1982. Humulin® was approved for use in Australia in 1986.

The first biosimilar medicine approved in the European Union was somatropin in 2006. It was developed by Sandoz and marketed under the brand name Omnitrope®. Somatropin is used to treat children’s growth disorders and adult growth hormone deficiency.

In August 2008, Australia adopted a number of international guidelines from the European Medicines Agency about the regulation and evaluation of biosimilar medicines.

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 listed on the Australian Register of Therapeutic Goods (ARTG). In July 2013, the TGA evaluation of biosimilars was published, and 4 more biosimilar medicines were listed on the ARTG from 2013 to 2015. In December 2015, the TGA updated the regulation of biosimilar medicines, and 2 more medicines were listed on the ARTG in 2016. Seven of these medicines (Novicrit, Nivestim, Omnitrope, Tevagrastim, Zarzio, Inflectra and Bemfola) are also listed on the Pharmaceutical Benefits Scheme.

The approval and use of biosimilar medicines has steadily grown since their introduction in 2006. Biosimilar medicines are available for patients in more than 60 countries around the world.

Biosimilar medicines are currently used in five main clinical areas (in order of their appearance on the market):

  • Human growth hormone, also known as somatropin, stimulates growth, cell reproduction and regeneration in humans. It is used to treat children’s growth disorders and adult growth hormone deficiency.
  • Epoetin controls red blood cell production and is commonly used in combination with dialysis and oncology treatments.
  • Filgrastim (granulocyte colony-stimulating factor; G-CSF) stimulates the bone marrow to produce granulocytes and stem cells, and release them into the bloodstream. Filgrastim is used with certain cancer patients to accelerate recovery from neutropoenia after chemotherapy, allowing higher-intensity treatment regimens.
  • Insulin—specifically glargine—is a long-acting analogue used for basal dosing in type I and type II diabetes.
  • Antitumour necrosis factor therapies—specifically infliximab—are monoclonal antibodies 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, publishing its initial regulatory guidelines in 2005. Since then, 19 biosimilar medicines have been approved and used by patients in the European Union. In 2010, the World Health Organization (WHO) published their Guidelines on evaluation of similar biotherapeutic products. In the rest of the world, the European Union regulatory framework and WHO guidelines have been used as models for biosimilar medicine regulation.

Since their development in the 1980s, biosimilar medicines have developed into a $3 billion [1] market worldwide (2015), [2] although uptake has varied between countries.

There is significant potential for growth in the global biosimilar medicines market in the next 10–20 years, as the patents on many reference biological medicines expire. The global biosimilar medicines market is predicted to reach $8.2 billion by 2020.[3]

[1] Note: all values have been converted to Australian dollars.

[2] MarketsandMarkets (2015). Biosimilars market by product and application: global forecast to 2020, MarketsandMarkets, Pune, India.

[3] MarketsandMarkets (2015). Biosimilars market by product and application: global forecast to 2020, MarketsandMarkets, Pune, India

Biosimilars have been used in Australia since 2010, and access has been predominantly in the hospital setting.

Three of the main biosimilar medicines are epoetin lambda, filgrastim and infliximab. A review of all brands of filgrastim and epoetin prescriptions dispensed from July 2013 until December 2015 showed that these medicines are used differently in each state or territory. For example, South Australia and Queensland currently have a substantially higher uptake of the epoetin biosimilar compared with other states and territories. The differences are indicative of the way public hospital systems decide on formulary listings. Each hospital—or in some instances, groups of hospitals within a state or area health service—have a committee who regulate and govern the use of medicines in their health service organisation.

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