Australia approves five biosimilars since June 2019 Posted 06/12/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

Apotex’s pegfilgrastim biosimilars Lapelga and Neutropeg (Apo-Peg) were accepted for review by the TGA on 31 August 2018 and were approved on 19 August 2019. Lapelga and Neutropeg are indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia (low white blood cell count) and so reduce the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever). A ‘similar biologic’ of Apotex’s pegfilgrastim product (Apo-Peg) called Neupeg was approved in India in August 2007 [1]. Lapelga was approved in Canada in May 2018 [2] and the product was also approved by the European Commission (EC) as Pelgraz in September 2018 [3]. Apotex also submitted its candidate pegfilgrastim biosimilar to the US Food and Drug Administration (FDA) for approval in December 2014 [4].

Pfizer’s trastuzumab biosimilar Trazimera was accepted for review by the TGA on 1 August 2018 and was approved on 19 August 2019. Trazimera is indicated for the treatment of human epidermal growth factor receptor 2 positive (HER2+) early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy. Trazimera was also approved by the EC in July 2018 [5], by Japan’s Ministry for Health Labour and Welfare (MHLW) in September 2018 [6] and by FDA in March 2019 [7].

Pegfilgrastim biosimilar Ziextenzo, made by Sandoz, was accepted for review by the TGA on 28 September 2018 and was approved on 6 September 2019. Ziextenzo is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia. Ziextenzo was also approved by the EC in November 2018 [8] and by FDA in November 2019 [9].

Finally, Pfizer’s Zirabev was accepted for review by the TGA on 31 October 2018 and was approved on 21 November 2019. Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. Zirabev was also approved by the EC in February 2019 [3] and by Japan’s MHLW in June 2019 [10].

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Biosimilars approved in Australia

References
1. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2. GaBI Online - Generics and Biosimilars Initiative. Pegfilgrastim biosimilar Lapelga approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/Pegfilgrastim-biosimilar-Lapelga-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
5. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars gain EC approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-gain-EC-approval
6. GaBI Online - Generics and Biosimilars Initiative. Originator biologicals and biosimilars under attack in UK and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/General/Originator-biologicals-and-biosimilars-under-attack-in-UK-and-Japan
7. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Trazimera [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Trazimera
8. GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilars-Pelmeg-and-Ziextenzo
9. GaBI Online - Generics and Biosimilars Initiative. FDA approves pegfilgrastim biosimilar Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-pegfilgrastim-biosimilar-Ziextenzo
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

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