PIC reports to Ministers on treatment of similar biologics

The Pharmaceuticals Industry Council (PIC) has been considering the issue of regulation of similar biologic medicinal products (SBMPs), and specifically their treatment for reimbursement, following a request by the former Minister for Health and Ageing 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.

The PIC has agreed that at present the science used in the development, analysis and regulation of biologics and SBMP, unlike small molecule medicines, does not routinely support pharmacist substitution between different brands of the same biological molecules once a patient has started on a treatment.

The group also reached agreement that because of the rapidly evolving scientific knowledge supporting market entry and commercialisation, there is merit in these types of molecules being differentiated with respect to their management on the PBS. However, the group does not agree on the finer details or treatment within specific formularies.

After considering the range of issues raised in discussions, AusBiotech supports the position that despite their clear differences, if they were differentiated within the formulary, biosimilar medicines could be treated within the current system.

The SBMP and their comparator biologic could move into F2 and take the standard 16% mandatory price cut, providing there is differentiation between small molecules and biologics in F2 as designated by an asterisk (*). AusBiotech also agrees with the proposal to extend the price disclosure data collection period for these medicines marked with an asterisk (*) from 12 months to 24 months.

AusBiotech wants a process that generates sufficient competition in the generics market for the Government, whilst ensuring sufficient time for the market for a biosimilar to evolve to take account of the relative newness of this technology and market. It believes that extending the price disclosure data collection period to 24 months will provide that period for the market to evolve and develop.