Mundipharma announced on 13 January 2020 that it had entered into a partnership with Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) to commercialize four biosimilar candidates from Samsung Bioepis in Hong Kong and Taiwan.
The partnership covers biosimilar candidates from Samsung Bioepis in the field of immunology and oncology and includes SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab) and SB8 (bevacizumab).
Mundipharma Singapore, which covers a global network across Asia Pacific, Latin America, the Middle East and Africa, is in charge of the partnership. Mundipharma will be the exclusive commercialization partner, while Samsung Bioepis will remain the Marketing Authorisation Holder (MAH), responsible for clinical development, regulatory registration and manufacture of the biosimilars.
The adalimumab biosimilar, SB5, was approved as Imraldi by the European Commission (EC) in August 2017. It was also approved as Hadlima by Korea’s Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration, in September 2017, by Australia’s Therapeutic Goods Administration (TGA) in January 2018 and by Health Canada in May 2018 [1].
The etanercept biosimilar, SB4, was approved as Brenzys in South Korea in September 2015, in Australia in July 2016. and in Canada in August 2016. It was also approved as Eticovo by the US Food and Drug Administration (FDA) in April 2019 and as Benepali by the EC in January 2016 [2].
The trastuzumab biosimilar, SB3, was approved in Europe in November 2017, by Korea’s MFDS on 9 November 2017 and was submitted to FDA for approval in December 2017 [3].
Samsung Bioepis also submitted the application for approval for its proposed bevacizumab biosimilar, SB8, to the European Medicines Agency (EMA) in July 2019 [4].
The partnership between Mundipharma and Samsung Bioepis is reported to be valid for a period of 10 years. However, timelines for launching the four biosimilars in Hong Kong and Taiwan were not provided.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-from-Samsung-Bioepis
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