The Parliament has passed changes on the regulation and reimbursement of biosimilars despite Senators acknowledging significant concerns held by a wide cross-section of stakeholders.
The Bill provides both the Minister with a decision-making power regarding biosimilar equivalence and the Pharmaceutical Benefits Advisory Committee with a specific function to provide advice to the Minister on the same subject.
A brief Senate inquiry on the Bill heard evidence from a range of stakeholders, including AusBiotech, expressing concern over the changes in relation to biosimilars.
"This proposed amendment gave rise to significant concern across a range of interested entities," said the final report of the inquiry.
In its submission, AusBiotech said, "The proposed provisions appear to allow the substitution in the absence of scientific evidence of safety and efficacy if this is the case, AusBiotech wishes to covey its concern at such a move."
According to the inquiry's final report, "A common argument made by many witnesses was that while they supported the greater use of biosimilars in Australia, they had concerns about pharmacy-level substitution of biologic medicines with biosimilars."
The concerns were echoed by the Consumers Health Forum.
"This is a premature move in our opinion, given the paucity of evidence on the safety of switching patients from a biologic to a biosimilar," it said. "We have had a number of representations from very concerned consumer groups for people who have taken a long time to get onto a biologic and are worried that they will then have to switch to a biosimilar and they are not sure what the effect on them will be. We believe that any switching should be only done with the informed consent of the consumer and the prescribing doctor."
The report recommended that such concerns be resolved through ongoing consultation on "improved administrative processes."
It also noted that submitters, including AusBiotech, were of the "firm view" that the TGA should have a far more substantial role in advice to the Minister on biosimilar substitution.
The report said the Government should engage in a "broad and transparent public consultation across all stakeholders, including industry, clinicians and patient organisations, with the aim of producing informed guidance on how and under what circumstances 'a' flagging of biosimilar medicines could occur."