Development of biosimilar medicines


A biosimilar medicine is a highly similar version of an original brand of a biological medicine, brought to market by a different manufacturer once the patent on the original brand expires.

The reason these medicines are known as biosimilar medicines, and not as generic medicines, is because biological medicines are large molecules made from living cells, and so the processes that produce them are naturally variable. This means that no two batches are ever exactly the same – not even from the same manufacturer.

Biosimilar brands of biological medicines are used to treat the same diseases, in the same way and have been thoroughly tested by the TGA in Australia to show that they are just as safe and effective as the original brands of biological medicines.

Biosimilar medicines have the potential to generate substantial cost-savings for the Australian healthcare system. When a biosimilar medicine becomes available in Australia, it encourages market competition between manufacturers, which in turn, can make these high-cost medicines more affordable for the Australian Government to subsidise. As most medicines in Australia are subsidised through the Pharmaceutical Benefits Scheme (PBS), these lower prices allow the Government to use the cost-savings to subsidise more medicines or spend more on other areas of healthcare.