Prestige announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA) [1].

Prestige is seeking approval for its biosimilar in the same indications as the reference product (Herceptin). In addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials, the submission includes data from Prestige’s phase I/III global clinical trial of HD201. This trial, according to the company, ‘confirms that HD201 is exceptionally similar to Herceptin in terms of clinical response and PK [pharmacokinetic]’ [1].

The agreement will enable the Mundipharma network to distribute, market and sell Tuznue in France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria following marketing authorization.

Mundipharma Europe’s CEO, Alberto Martinez, says that the company now partners with three different companies on biosimilars and also has its own in-house development, regulatory, IP and commercialisation capabilities. One of these agreements was made with South Korean biotechnology company Celltrion. This exclusive agreement was made back in September 2014 and enables Mundipharma to distribute Celltrion’s infliximab biosimilar in Belgium, Germany, Italy, Luxembourg, The Netherlands and the UK [2]. Mundipharma has also partnered with Celltrion to distribute its trastuzumab biosimilar, Herzuma.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar from Prestige accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 30]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-from-Prestige-accepted-for-review-by-EMA
2. GaBI Online - Generics and Biosimilars Initiative. Infliximab biosimilar to be distributed by Mundipharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 30]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-biosimilar-to-be-distributed-by-Mundipharma

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