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Australia approves three biosimilars in first half of 2019

Biosimilars/General | Posted 23/08/2019 0 Post your comment

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.

Trastuzumab biosimilar Ontruzant, made by Samsung Bioepis, was accepted for review by the TGA on 1 February 2018 and was approved on 9 January 2019. Ontruzant (powder for injection) is also indicated for the treatment of HER2+ (human epidermal growth factor receptor 2 positive) early breast cancer and HER2+ locally advanced breast cancer in combination with chemotherapy, as well as for metastatic breast cancer and advanced gastric cancer. Ontruzant has also been approved in Europe and in South Korea in November 2017 [1, 2]. It was also submitted to FDA for approval in December 2017 [3].

Amgen’s trastuzumab biosimilar Kanjinti was accepted for review by the TGA on 22 December 2017 and was approved on 16 May 2019. Kanjinti (powder for injection) is indicated for the treatment of HER2+ early breast cancer and HER2+ locally advanced breast cancer in combination with chemotherapy, as well as for metastatic breast cancer and advanced gastric cancer. Kanjinti has also been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in June 2019 and March 2018, respectively [4, 5].

Finally, Sandoz’s Hyrimoz was accepted for review by the TGA on 30 August 2017 and was approved on 1 March 2019. Hyrimoz is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis. Hyrimoz was also approved by EMA in June 2018 [6] and was submitted to FDA in January 2018 [7].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Kanjinti
5. GaBI Online - Generics and Biosimilars Initiative. EMA approval for trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-trastuzumab-biosimilar-Kanjinti
6. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-trastuzumab-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars

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Source: TGA