PBS listing of Biosimilar Inflectra (Infliximab) raises concerns about pharmacy level substitution

What has occurred? 

The Australian Pharmaceutical Benefits Advisory Committee (PBAC) has made the decision to list the biosimilar Inflectra (Infliximab) on the PBS as a treatment for inflammatory arthritis. This decision is welcome as the availability of biosimilars has the potential to decrease costs and increase consumer choice and access to biologic medications.

However, less welcome is the PBAC recommendation that pharmacists be allowed to substitute this biosimilar for the original biologic medicine, as they do with generic medicines, without seeking advice from a treating doctor.  

What are our concerns?

Biosimilars are not to be confused with generic versions of medications. Biologic medications are extremely complex molecules grown using living organisms created in a very specific scientific environment. It is the complexity of these molecules and processes which make replicating them exactly, virtually impossible. As a result it can’t be assumed, without additional evidence, that a biologic and its biosimilar can be used interchangeably.

The potential effects of switching between a biologic and its biosimilar counterpart are not yet fully known, sos our concern is that allowing pharmacy level substitution may create issues for safety and efficacy.. Furthermore, this pharmacy level substitution may impede the ability to monitor the safety and efficacy of the therapy in the longer term.

Our partners at Arthritis Australia released a media release outlining their concerns relating to this development. To view this release please click here or to read the Arthritis Australia fact sheet on biologic medicines and biosimilars click here.

What should you do?

We stress that you should always speak to your rheumatologist when making any decision regarding changes to your medications. 

What is being done?

In response to this development a joint letter from Arthritis Australia, the Australian Rheumatology Association, the Gastroenterological Society of Australia,  Crohn’s and Colitis Australia and other key clinical and patient groups has been sent to the Federal Minister for Health and the PBAC chair.