Australia approves etanercept and insulin aspart biosimilars

Biosimilars/News | Posted 04/12/2020 post-comment0 Post your comment

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), announced in October 2020 the approval of etanercept and insulin aspart biosimilars.

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Etanercept is a is a human tumour necrosis factor receptor p75 fragment crystallizable fusion protein and is a drug used to treat inflammatory conditions. This latest biosimilar has been approved for the treatment of rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis in adults. It has also been approved for the treatment of several juvenile arthritic conditions and juvenile plaque psoriasis.

On 23 October 2020, the TGA also announced the approval of the insulin aspart biosimilar Truvelog for the treatment of diabetes mellitus. Truvelog, which is made by Sanofi-Aventis, is a biosimilar of NovoRapid Penfill and NovoRapid FlexPen. This will be the first rival of the reference product to enter the Australian market.

Insulin aspart is a type of manufactured insulin that is administered by injection to control blood sugar levels in people with type 1 and type 2 diabetes. It acts more rapidly than normal human insulin (within 15 minutes) and its effects last for 3–5 hours.

Sanofi also received approval for its insulin aspart biosimilar in Europe in July 2020 [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from:
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for Sanofi’s insulin aspart biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from:

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Source: TGA

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