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Biosimilar infliximab blocked in Australia Posted 29/06/2018

Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.

Sandoz gained approval from Australia’s Therapeutic Goods Administration (TGA) for its rituximab biosimilar Rixymio in November 2017 [1]. But Roche, which has sold the originator biological MabThera in Australia since 1999, claims that Sandoz threatens to infringe certain claims of four of its rituximab patents related to methods for using rituximab to treat various conditions, including certain cancers and rheumatoid arthritis.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The lawsuit by Roche was prompted by Sandoz applying to have Riximyo listed on the Pharmaceutical Benefits Scheme (PBS). Roche argued that without the injunction, Sandoz’s products would likely be listed on the PBS on 1 August 2018 and that it would suffer incalculable harm. Sandoz, on the other hand, argued that Roche’s patents were invalid due to lack of inventiveness and obviousness, and that the injunction sought was too broad.

Justice Stephen Burley agreed with Roche that Sandoz’s claims of invalidity and obviousness were merely arguable and not highly arguable. The judge also agreed with Roche that it would suffer considerable loss unless the injunction was granted, including loss of market share, and that if it were successful it would not be able to raise the prices for its drug back to earlier levels.

For Roche, the introduction of Riximyo to the PBS would automatically cause a 16% price reduction for MabThera by moving it from the F1 to F2 PBS formulary. Furthermore, it was expected that Sandoz would reduce the price of Riximyo more than the mandatory 16% to attract customers away from MabThera, with evidence from the UK suggesting a possible price reduction in the order of 40% or more.

This marks the first case of its kind in Australia but is likely not to be the last, given the PBS reimbursement consequences.

The end date for the injunction has been set as 11 August 2019.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia

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Source: Lawyerly, Mills Oakley

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