Publication of the details of the PBS savings package has confirmed that, in what is a world first, Australia will back substitution of biosimilars for their reference biologic.
Release of the details of an agreement between the Government and Generic Medicines Industry Association has confirmed that the default position of the Pharmaceutical Benefits Advisory Committee (PBAC) will be to 'a' flag biosimilars with their reference biologic.
The agreement says that the PBAC's consideration of all future biosimilars will start from the basis of 'a' flagging to the reference biologic "where clinical evidence does not support a contrary view".
Products that are 'a' flagged are substitutable.
While largely anticipated, the adoption of a policy that on the surface appears to promote across-the-board substitution has shocked many in industry, primarily because it would represent a profound and fundamental shift in Australia's approach to the regulation and reimbursement of medicines.
The TGA is currently reviewing its biosimilars guideline, but the existing document published in July 2013 says that a biosimilar's Product Information should include a statement ruling out substitution.
As one industry source wryly noted to BiotechDispatch, "...if biosimilars are just generics, then why has every Government around the world, including in Australia, developed and implemented approval processes that clearly distinguish them from generics."