Australia's PIC reports to Ministers on treatment and reimbursement of similar biologics

14 June 2012

The Australian Pharmaceuticals Industry Council (PIC), with industry group members AusBiotech, Medicines Australia and the GMiA (representing generic drugmakers), has today reported to the federal government on the preferred treatment of follow-on biologics for reimbursement.

The PIC has been considering the issue of regulation of similar biologic medicinal products (SBMPs) - also known as biosimilars - and specifically their treatment for reimbursement, following a request by the former Minister for Health and Aging for the PIC to try to reach a sector-wide consensus on a policy for managing the listing and pricing of biosimilars on the Pharmaceutical Benefits Scheme (PBS).

The development of SBMPs and their governing regulations is an unsettled and evolving area in Australia and internationally, as regulatory authorities and payers worldwide are struggling to create the most appropriate pathways for this class of medicines based in its unique issues.

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