TGA approves three biosimilars but fewer generics in 2017

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Australia’s Therapeutic Goods Administration (TGA) approved fewer generics in 2017 (101) compared to 2016 (118). However, 2017 also saw a large proportion of new registrations of immunotherapies and human monoclonal antibodies, while the listing of new ‘first generic’ medicines triggered a statutory 16% price reduction under the Pharmaceutical Benefits Scheme (PBS). In addition, the agency also approved three new biosimilars.

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TGA released its fourth annual summary report on the registration of prescription medicines, which includes new generics and biosimilars, on 29 January 2018.

Of the 101 generics registered during 2017, 29 submissions resulted in the registration of the ‘first generic’ version that contains a particular active ingredient. The term ‘first generic’ is the first registration approval by TGA which permits a sponsor to market a generic drug product in Australia. First generics are significant because they create more affordable treatment options for patients – the listing of a first generic triggers a 16% price reduction under the PBS.

TGA also approved three biosimilars in November 2017. Amgen’s Amgevita (adalimumab) was approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, and uveitis. The etanercept biosimilar Erelzi from Novartis was approved for the treatment of ankylosing spondylitis, juvenile idiopathic arthritis, paediatric psoriasis, psoriatic arthritis, psoriasis and rheumatoid arthritis. Finally, Sandoz gained approval for its rituximab biosimilar Riximyo, which is indicated for the treatment of B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, Wegener’s granulomatosis, and microscopic polyangiitis.

These approvals mark the first monoclonal antibodies to be approved in Australia and bring the total number of biosimilars approved in the country to 16 [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from:

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Source: TGA

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