Patient safety must not be pushed aside in government quest for biosimilars budget savings

PBAC

Arthritis Australia is concerned that patient safety may be compromised by current moves in Australia to allow biosimilars to be substituted for biologic medications at the pharmacy level.

Biologic medications are used to treat a number of auto-immune forms of arthritis, including rheumatoid arthritis and juvenile arthritis.  People with auto-immune forms of arthritis are one of the largest patient groups in which these medications are used.

Many biologics used for arthritis are now starting to come off patent and copies, known as biosimilars, are beginning to enter the market. 

While biosimilars are very similar copies of biologic medications they are not generics. Biologic medications are extremely complex molecules grown using living organisms and it is virtually impossible to replicate them exactly.  Consequently it cannot be assumed that a biosimilar can be used interchangeably with its biologic reference product.

Switching between a biologic and its biosimilar may increase the risk of adverse events and may impede safety monitoring.  Clinical evidence on the safety and effectiveness of patients switching between a biologic and a biosimilar is currently limited.

For more details, go to: http://www.arthritisaustralia.com.au/index.php/63-news/286-patient-safety-must-not-be-pushed-aside-in-government-quest-for-biosimilars-budget-savings.html

Michael Wonder

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Michael Wonder

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