Celltrion to use cloud-based technology for its biosimilars trials

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Celltrion to use cloud-based technology for its biosimilars trials

Biosimilares/General | Posted 19/02/2016 0 Post your comment

On 20January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).

Celltrion conducts more multi-regional clinical trials than any other life sciences company in Korea and will rely on the Medidata Clinical Cloud to enhance the speed, efficiency and accuracy of its clinical trials.

US-based Medidata’s cloud-based technology will provide the flexibility and simplicity in Celltrion’s research technology platforms that the company requires for its research into the therapeutic impact of large and complex molecules.

The company believes that ‘Medidata can help Celltrion in its effort to accelerate and expand access to advanced therapeutics for patients around the world’, according to Mr Sang-Joon Lee, Celltrion’s vice president. While Mr Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific (APAC) region, said ‘the life sciences industry is rapidly growing in Asia, especially in the burgeoning field of biosimilars, and Medidata is excited to be partnering with a company like Celltrion that is at the forefront of this growth.’

Celltrion’s infliximab biosimilar (Remsima) was approved by the European Medicines Agency (EMA) in September 2013 [1]. The company filed its biosimilar application for CT-P13 (infliximab) in the US back in August 2014, claiming it to be the first monoclonal antibody application to be filed in the US [2]. Celltrion’s rituximab biosimilar (CT-P10) was submitted to EMA on 10 November 2015 [3]. The company has also started a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) [4].

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Korean approval for infliximab biosimilar

References
1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2.  GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
3.  GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA
4.  GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial

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Source: Celltrion, Medidata