Eye on Pharma: Australia Approves Its First Trastuzumab Biosimilar

Australia’s Therapeutic Goods Administration (TAG) has approved Celltrion’s Herzuma—the country’s first biosimilar trastuzumab—referencing Herceptin.

While Celltrion is in discussions with affiliates concerning distribution channels for the drug approved to treat HER2-positive cancers, it has not yet decided on a launch date. "We will do our best to quickly enter the market so that cancer patients in Australia can benefit from high-quality biopharmaceuticals at a reasonable price," the Korean drug maker indicated in a corporate statement.

The trastuzumab biosimilar will join 2 other anticancer biosimilars on the list of TAG’s approved biosimilars—2 rituximab products referencing Rituxan have been approved. Other biozimilars authorized in Australia include adalimumab, etanercept, infliximab, filgrastim, epoetin alfa, insulin glargine, and follitropin alfa. (Unlike the United States, Australia addresses follow-on insulins and human follicle-stimulating hormones as biosimilars.)

Many of these products are reimbursable on the national Pharmaceutical Benefits Scheme, and 3 have been designated as substitutable for their reference products at the pharmacy level: Brenzys (an etanercept biosimilar referencing Enbrel), Renflexis, and Inflectra (both infliximab biosimilars referencing Remicade).

Australia has been making a marked effort to increase its uptake of biosimilars, and recently announced that it would implement 2 “uptake drivers” as a matter of national policy: encouraging prescribing of biosimilars over branded drugs for new patients, and providing a faster and simpler preapproval process for patients to receive a biosimilar drug than a branded drug. The drivers, say the Australian government, are expected to be time-limited initiatives that will support the acceptance of these products and positively impact market behavior.

The first product to become subject to the uptake drivers was Brenzys in December 2017, followed by both infliximab biosimilars in July 2018. The government published fact sheets on the biosimilars, with separate documents made available to prescribers, pharmacists, and patients or their caregivers.

The decision to institute the drivers follows 2016 research from Australia’s Department of Health that found that specialist physicians and pharmacists were significantly more likely to prescribe and dispense branded biologics than biosimilars, a finding that was seen to be a function of specialists’ concerns about biosimilarity and about switching stable patients from reference to biosimilar products.