Australia's Embrace of Biosimilars Continues With Authorization of Celltrion's Rituximab

Republic of Korea—based Celltrion has announced that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima, referencing MabThera, for the treatment of non-Hodgkin lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Celltrion is currently determining with whom it will partner on commercialization of the drug, and it has not yet disclosed the timing of its launch in the Australian marketplace.

In addition to Truxima, Australia’s TGA has approved Sandoz’s Riximyo, also referencing Roche’s MabThera. The TGA’s most recent update to its list of approved biosimilars includes biosimilars of adalimumab, etanercept, infliximab, filgrastim, epoetin alfa, insulin glargine, and follitropin alfa. (Unlike the United States, Australia addresses follow-on insulins and human follicle stimulating hormone as biosimilars.)

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

Australia has been seeking to support the approval and uptake of biosimilar medicines as a way to alleviate pressure on its national health system. One of its policy moves has been a Strategic Agreement between the government and the Generic and Biosimilar Medicines Association (GBMA), an organization whose members include the Association for Accessible Medicines, Medicines for Europe, and the Canadian Generic Pharmaceutical Association, among others. Under the agreement, which operates until 2020, the Australian government commits to recommending biosimilars for treatment-naïve patients and promoting biosimilar prescribing through requiring a lower level of authorization for the biosimilar than for the reference biologic.

The GBMA in turn agrees to a 25% statutory price reduction on the PBS formulary listings of the first new biosimilar brands and applying additional price reductions to products that have been listed on the formulary for 10 years or more.

Furthermore, the government has awarded a $5 million (approximately $3,805,000 USD) grant to GBMA to undertake biosimilar education activities for prescribers, pharmacists, and patients. According to the government, the expected outcomes of the grant include raising awareness of the availability of biosimilars, building understanding of biosimilars and the regulatory process, guiding the integration of biosimilars into daily clinical practice, and developing continuing education programming on biosimilars for healthcare providers.

The government currently provides access to ongoing literature reviews of international and Australian clinical, academic, and policy journals and media articles concerning biosimilars for the purpose of informing policy development and communication with the government’s biosimilar awareness initiative.