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FDA approves trastuzumab biosimilar Ontruzant Posted 25/01/2019

On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.

The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had sales of CHF 7.0 billion (US$7.5 billion) in 2017 [1]. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [2]. 

Ontruzant is produced by South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis. The company first submitted its application for approval to FDA in December 2017 [3].

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 and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Ontruzant has been approved across all eligible indications, namely adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

Ontruzant has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

The approval of Ontruzant marks the second biosimilar from Samsung Bioepis to be approved by FDA. Renflexis (infliximab-abda) was approved in the US in April 2017 [4].

Samsung Bioepis also received European approval for its trastuzumab biosimilar, Ontruzant, in November 2017 [5].

Ontruzant will be marketed and distributed in the US by Merck, which is known as MSD outside of the US and Canada.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant

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Source: Samsung Bioepis, US FDA

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