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Teva and Celltrion to partner on biosimilars Posted 14/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.

The collaboration involves Celltrion’s candidate rituximab biosimilar, Truxima (CT-P10), and its candidate trastuzumab biosimilar, Herzuma (CT-P6). Both candidate biosimilars are currently in late-stage phase III development [1] and their primary endpoints have been successfully achieved, according to Teva.

Celltrion submitted its marketing application for its rituximab biosimilar (CT-P10) to the European Medicines Agency in November 2015 [2]. The product is a biosimilar of Roche’s MabThera/Rituxan (rituximab), which is indicated for the treatment of lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The company’s trastuzumab biosimilar, Herzuma, has been marketed in South Korea since January 2014, following approval by the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration) [3]. The product is a biosimilar of Roche’s Herceptin (trastuzumab), which is indicated for the treatment of certain breast cancers.

The total revenues from these two drugs in the US and Canada, according to Celltrion and Teva, amount to approximately US$6.5 billion, which is half of the global sales. Assuming that Truxima and Herzuma take just 20% of that market, an annual revenue of US$1.3 billion may be expected. This Celltrion expects to be reasonable, considering that it is estimated that its infliximab biosimilar Remsima took 40% of the European market in just one year.

Under the terms of the agreement, Teva will pay Celltrion US$160 million upfront of which up to US$60 million is refundable or creditable under certain circumstances. Teva will be responsible for all commercial activities in the US and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities. The two companies will share profit from the commercialization of the two biosimilars.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea

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Source: Celltrion, Teva

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