Australia gives its nod to Trastuzumab Biosimilar

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

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.

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.

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