"Complete disbelief" is how industry sources are describing the global response to speculation Australia will back substitution of biosimilars for their reference biologic.
In conversations with global sources, representing the pharmaceutical and biotechnology sectors, BiotechDispatch has been told by one senior US-based industry executive they "simply can't believe that a highly developed and well-regulated market would take such a radical step."
Another US-based source said any change that assumed substitution as the base case for the reimbursement of biosimilars would put Australia "well and truly" at odds with virtually every other developed country market.
"Especially when it comes to safety," they said.
In the outcomes statement from its March meeting, the Federal Government's chief drug-funding advisory body, the Pharmaceutical Benefits Advisory Committee, indicated that it would consider marking biosimilars equivalent (i.e. 'a' flagging) with their reference biologic on a case by case basis, "taking into account the evidence presented in each submission to list a biosimilar medicine."
The Committee also confirmed that it had "further considered PBS subsidy of biosimilar medicines at its special meeting on 17 April 2015. The outcomes of that meeting will be published separately."
BiotechDispatch understands that, at this meeting, the PBAC considered the potential shift in the 'burden of proof' from biosimilar to reference biologic, which could mean that its consideration of all future biosimilars will start from the basis of 'a' flagging to the reference biologic.
It remains unclear precisely what 'a' flagging for a biosimilar might mean but, in the case of small molecule generics, it means substitution is permitted at pharmacy level.
Regardless, the speculation has attracted significant attention globally, with an "outspoken and vocal response" almost certain, according to industry sources.