Samsung Bioepis launches Ontruzant in Brazil Posted 11/09/2020

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South Korean biotechnology company Samsung Bioepis has announced the launch of their trastuzumab biosimilar Ontruzant in Brazil. The product was approved by the Brazilian health agency in May 2019.

Trastuzumab is a monoclonal antibody treatment for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric cancer. The antibody targets the HER2 receptor to stop the reproduction of cancer cells. The originator product, Herceptin, is sold by Roche/Genentech.

Trastuzumab is a monoclonal antibody treatment for breast and gastric cancer that is human epidermal growth factor receptor 2 positive (HER2+). It is given by injection and has been marketed by the originator manufacturer Roche/Genentech as Herceptin. 

Samsung Bioepis’ biosimilar trastuzumab is sold under the trade name Ontruzant and has been approved in the US [1] and Europe [2]. The product is also available in Australia, Korea and Ukraine.

Following Brazilian approval for the drug in May 2019 [3], the company announced in August 2020 that Ontruzant has now launched on the Brazilian market.

Ontruzant will be sold in 150 mg single-dose vials for the treatment of HER2-overexpressing breast cancer (metastatic and early stage) and advanced gastric cancer. Breast cancer is the most common cancer and the major cause of death for women in Brazil, where over 67,000 people are affected by breast cancer each year.

Commenting on the launch, Vice President of Samsung Bioepis Josh Sang Hyun Lee said: ‘The launch of our first oncology treatment Ontruzant in Brazil is a step closer to realizing our mission which is to deliver high quality, proven biological medicines to more people. We are confident that Ontruzant will make a positive impact on breast cancer patients in Brazil as we remain committed to leveraging our strengths in product development and quality assurance’. Ontruzant will be supplied to the Brazilian public health system, Sistema Único de Saúde, through a Productive Development Partnership (PDP) between Samsung Bioepis and two local partners, Bionovis and Bio-Manguinhos. 

Ontruzant is Samsung Bioepis’ second product to be launched in Brazil, following the launch of the company’s etanercept biosimilar Brenzys through a similar PDP in September 2019 [4]. Ontruzant will also be the first trastuzumab biosimilar to be supplied to the Brazilian public health system.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ontruzant  
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant  
3. GaBI Online - Generics and Biosimilars Initiative. Brazilian approval for trastuzumab follow-on biological Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/Brazilian-approval-for-trastuzumab-follow-on-biological-Ontruzant  
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis to supply Brenzys to Brazil under production development partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-to-supply-Brenzys-to-Brazil-under-production-development-partnership 

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Source: Samsung Bioepis

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