Home / Biosimilars / General / Australia approves three biosimilars in first half of 2019

Australia approves three biosimilars in first half of 2019 Posted 23/08/2019

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].

Related articles
Biosimilars of adalimumab

Biosimilars of trastuzumab

Biosimilars approved in Australia

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: TGA

Comments (1)

best cure posted 22/09/2019 - by mary johnson

ALL THANKS TO DR OSO WITH HIS HERBAL PORTION I WAS COMPLETELY CURED FROM BREAST CANCER.  I'm here again to appreciate. DR OSO God will always continue to bless you more abundantly, for the good works you don in my life, I will always keep on writing good and posting my testimonies about you on the Internet, I’m MARY JOHNSON from TEXAS . I was tested breast cancer positive, I saw a blog on how DR OSO cured people with his herbal portion, i did not believe in natural medicine but i just decided to give him a try, I contacted him,and explain my situation to him,few day later he sent me the herb, after taking DR OSO  herbal medicine for few weeks i went to hospital for check up so luckily i was healed  with his herbal portion, i am so happy. If you have any type of cancer problem or you are also infected with any kind of disease, contact him drosohaberhome@gmail.com or call/whatapp +2348162084839 for advice and for his product,i hope this testimony also help some one out there ..              here is the  dr website. https://sites.google.com/view/drosohaberhome/ His blog page https://drosohaberhome.blogspot.com you can also email me for more info about DR oso  via maryjohnson9700@gmail.com     ALL THANK TO DR OSO .

Generics News Research General

more

Biosimilars News Research General

more