Trastuzumab and Bevacizumab products approved in Australia and Argentina

Biosimilares/Novedades | Posted 07/09/2018 post-comment0 Post your comment

Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.

Approved V13G05

Korean biopharmaceutical firm Celltrion announced on 2 August 2018 that its breast cancer biosimilar Herzuma (trastuzumab) had been approved by Australia’s regulatory body, the Therapeutic Goods Administration (TGA).

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Herzuma is a biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 7.0 billion (US$7.5 billion) in 2017. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [1].

Herzuma (CT‑P6) has also been approved in South Korea [2] and the European Union [3]. Celltrion has also submitted applications for approval of CT‑P6 in the US [4] and Japan [5].

Argentina-based Laboratorio Elea announced in August 2018 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its ophthalmic medicamento biológico similar Lumiere (bevacizumab).

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A).

Lumiere has been approved by ANMAT for the treatment of eye diseases, such as age-related macular degeneration (AMD) and diabetic retinopathy, which damage the retina and cause blindness after blood vessels grow and detach the layers of the retina.

Elea says that Lumiere will cost ARS 5,000 (US$180), which compares favourably with the cost of Lucentis (ranibizumab) ARS 50,000 (US$1,800), which is produced by originator manufacturer Novartis.

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1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1): 29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar trastuzumab to FDA []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion making progress with biosimilars in China and Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from:

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Source: Elea, The Investor, TGA, YonHap

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