Updated: Etanercept biosimilar listed on the PBS

The etanercept biosimilar Brenzys™ has been listed on the PBS for use in adults with severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, and severe chronic plaque psoriasis.*

Marketed by MSD in Australia Brenzys™ is the first biosimilar of Pfizer’s originator drug Enbrel™.

While its listing has been welcomed by professional  bodies and consumer organisations concerns were expressed last September when the PBAC announced its decision to ‘a’ flag the biosimilar.

Speaking to the limbic at the time, chair of the ARA biosimilars working group Dr Mona Marabani said there was not enough evidence to support ‘a’ flagging.

“Most countries in Europe have laws AGAINST substitution. The EMA, which Australia often follows in making these decisions, makes no findings on interchangeability… There is still no naming convention in Australia, which makes traceability a problem,” she said.

She noted that there was data from phase 1 and phase 3 studies which indicated Brenzys was safe and efficacious.

Dr Marabani said the ARA made no recommendation about which drug to prescribe, but suggests that rheumatologists consider the options, decide what to prescribe (Enbrel or Brenzys) and ‘tick the box’, so that the patient receives the same medication every time.

“This is the reality of the situation, and it is now up to us as specialists to help our patients navigate this increasingly complicated environment in a way that maintains their safety and confidence.”

This week the department of health published information on biosimilars for consumer and healthcare professionals as part of its biosimilar awareness initiative.

*An earlier version of this article incorrectly stated Brenzys had PBS listing fornon-radiographic axial spondyloarthritis.

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