Australia's moves on biosimilar substitution draw flak from U.S. biologic medicines group

A move by Australia to be the first country to allow pharmacies in some cases to substitute biosimilars for originator drugs has drawn a rebuke by the U.S.-based Alliance for Safe Biologic Medicines (ASBM), which includes members such as Amgen ($AMGN) and the Biotechnology Industry Organization.

In late May, a Pharmaceutical Benefits Advisory Committee (PBAC) issued guidelines on how biosimilars could be "a"-flagged, or equivalent to the originator drug, allowing them to be substituted at the pharmacy level.

The move is part of a broader effort by the Australian government to rein in reimbursement costs by turning to a higher percentage of generics and biosimilars.

As part of that push, Australia signed 5-year agreements with the Generic Medicines Industry Association and the Pharmacy Guild of Australia on guidelines across the pharmaceutical supply chain.

PBAC recommends drugs for Australia's Pharmaceutical Benefits Scheme and had looked at the issue in March as something that could be done on a case-by-case basis.

In May, it firmed up the criteria, saying any decision to substitute needs to be made based on data covering clinical effectiveness and safety compared to the originator product and whether the Therapeutic Goods Administration has deemed a product to be biosimilar with the originator product.

The alliance, however, said that Australian Health Minister Sussan Ley and PBAC had broken with "widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement."

"There are good reasons that no country in the world currently uses automatic substitution--chief among them that treatment decisions involving these complex and sensitive medicines should be made by the physician and patient, not a third party."

However, on June 19, PBAC disputed media reports that the decision would be automatic.

"If the PBAC recommends the biosimilar should be substitutable this provides the option for clinicians and pharmacists to offer patients the choice of taking the original biologic drug or the substitute biosimilar drug, just as they currently do with generic versions of synthetic molecule drugs," the agency statement said.

"The PBAC's recommendation would, as always, give patients the ultimate choice as to which version of the drug they receive, again, just as they currently do with generic versions of synthetic molecule drugs. Also, clinicians would still have the ability to indicate a biologic drug is not to be substituted for a biosimilar for their patient if they do not consider it appropriate in that particular case."

- here's the ASBM release
- and the PBAC statement PDF)