Trastuzumab biosimilar Ontruzant launched in the UK Posted 23/03/2018

Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada, announced on 8 March 2018 that it had launched the trastuzumab biosimilar, Ontruzant, in the UK.

Ontruzant was originally developed by South Korean firm Samsung Bioepis, which is a joint venture between electronics giant Samsung and biotechnology company Biogen Idec.

Samsung Bioepis gained European Commission (EC) approval for Ontruzant on 20 November 2017 [1]. The EC approval followed the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 15 September 2017 [2].

Ontruzant will be commercialized in the European Union (EU) by MSD. The company made a biosimilars deal with Samsung Bioepis back in 2013 [3]. By 2015, the companies had five biosimilars programmes in phase III development and more biosimilars are expected to follow [4].

The biosimilar marks the fourth European approval for a biosimilar from Samsung Bioepis. The company has also gained EC approval for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab) [5].

Ontruzant is not the only trastuzumab biosimilar to be approved in the EU. Celltrion’s Herzuma (trastuzumab, CT‑P6) was approved by the EC in February 2018 [6].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
4. GaBI Online - Generics and Biosimilars Initiative. Merck outlines biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/Merck-outlines-biosimilars-programme
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma

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