Australia Allows Substitution of Biosimilar for Etanercept Brand

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). Considering the clinical evidence presented, PBAC recommended that there was “comparative safety and effectiveness of Brenzys and Enbrel.” Therefore, by substituting Enbrel for this biosimilar, approved indications, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, could be treated with Brenzys.

Brenzys was approved in Australia on July 22, 2016.  Merck & Co. Inc. in partnership with Samsung Bioepis holds rights in Australia to the Brenzys product, which is also approved in South Korea and Europe (marketed as Benepali).

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