Brazilian approval for trastuzumab follow-on biological Ontruzant

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Brazilian approval for trastuzumab follow-on biological Ontruzant

Biosimilares/Novedades | Posted 07/06/2019 0 Post your comment

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.

The registration of the cancer follow-on biological product was published in the country’s Official Gazette (Diário Oficial da União) on 16 May 2019. The company submitted the application for approval in Brazil 13 months earlier, in December 2017.

Ontruzant has been approved in Brazil to treat patients with early breast cancer, metastatic breast cancer and metastatic gastric cancer.

The Brazilian approval marks the fourth approval for the trastuzumab product from Samsung Bioepis. The company gained Korean approval for Samfenet (trastuzumab) in November 2017 [1], European approval for Ontruzant in November 2017 [2] and US approval for Ontruzant in January 2019 [3].

References
1. 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 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ontruzant

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Source: Diário Oficial da União, Korea Biomedical Review