In late April, 2015, The Pharmaceutical Benefits Advisory Committee (PBAC) pledged to consider marking biosimilar medicines equivalent to originator medicines, to which they are referenced against in Australia. This process would involve “a flagging”, whereby the biosimilar would be compared to the originator, in order to identify any significant differences in clinical efficacy or safety.
Should the PBAC apply “a flag” to a biosimilar medicine on the PBS, it would permit a pharmacist to substitute the biosimilar medicine for the originator, in the same way generic medicines are currently substituted.
This week, the PBAC declared its decision to make biosimilar products suitable for substitution at a pharmacy level – less than a month after the US FDA approved Sandoz’ oncology product, filgrastim-sndz, set to become the first biosimilar product available in the US.
Unlike biologic treatments, biosimilar therapies do not comprise one pure substance, but rather, are made up of mixed isoforms (any two or more functionally similar proteins that have a similar but non-identical amino acid sequence) of a desired substance. They are extremely complex medicines, but if approved, will allow consumers access to more treatments at reduced costs.