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].

Related article
Biosimilars of trastuzumab

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.