Mylan launches first trastuzumab biosimilar in Australia

Biosimilares/Novedades | Posted 23/08/2019 post-comment0 Post your comment

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.

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Trastuzumab is a monoclonal antibody, primarily used to treat breast cancer. It acts on the human epidermal growth factor receptor 2 (HER2), which is overexpressed in some types of breast cancer. Trastuzumab was approved for medical use in 1998 and is on the World Health Organization’s List of Essential Medicines.

Originally marketed by Roche as Herceptin, as patents have expired a raft of biosimilar versions have been approved across the globe. Mylan and Biocon’s biosimilar is named Ogivri and was most recently approved in Canada [1]. It has so far been approved in over 65 countries, including recent approval from the European Medicines Agency and US Food and Drug Administration. It is yet to launch in the US, however, where it will compete with Amgen’s trastuzumab biosimilar Kanjinti [2].

Mylan and Biocon now announce the launch of Ogivri in Australia. Ogivri can be used to treat HER2-overexpressing breast cancer and metastatic stomach cancer and is the first trastuzumab biosimilar to be launched in Australia, where it will be available on the Pharmaceutical Benefits Scheme (PBS), a government scheme which provides subsidised prescription drugs to citizens. The addition of Ogivri to this scheme should increase patient access to trastuzumab and generate cost savings for the Australian healthcare system. The drug is not however substitutable at the pharmacy level.

Australia has made significant efforts to create a competitive and sustainable biosimilars market. The Government committed to the Biosimilar Awareness Initiative in 2015 and more recently provided the Generic and Biosimilar Medicines Association with AU$5 million in funding to promote the use of biosimilars.

Mylan’s Australia manager Sylvain Vigneault said about the news: ‘Mylan's investment in biosimilars is an exciting evolution in how we can treat Australian patients. We are delighted that Ogivri enables Mylan, with our partner Biocon, to bring this treatment option to Australian patients with HER2-positive breast and gastric cancers’.

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1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar Ogivri approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Kanjinti []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from:

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Source: Biocon; Mylan

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