Samsung Bioepis and AffaMed to start trastuzumab trial in China Posted 17/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.

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.

SB3 has already been approved as Samfenet in Korea in November 2017 [1] and as Ontruzant in Europe and the US in November 2017 and January 2019, respectively [2, 3].

The clinical trial will be the first that Samsung Bioepis has carried out in China. It is planned to enrol 208 breast cancer patients and is expected to start in the first quarter of 2020. The aim of the trial is to demonstrate that SB3 is not different from the reference drug, Herceptin (trastuzumab), in terms of safety and efficacy.

The trial will be conducted in collaboration with AffaMed, a biopharmaceutical company focused on identifying and licensing late-stage candidates for commercialization. AffaMed was founded and funded by C-Bridge Capital. Samsung Bioepis signed a licensing agreement with China-based C-Bridge Capital in February 2019 to develop and commercialize next-generation copy biologicals in China [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan17]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-makes-deals-for-copy-biologicals-in-China

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Source: Korea Biomedical Review, Pulse

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