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].

Related article
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

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 © 2016 Pro Pharma Communications International. All Rights Reserved.