South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).
Celltrion submits rituximab biosimilar application to EMA
Biosimilars/News | Posted 20/11/2015 0 Post your comment
The application for approval of Celltrion’s rituximab biosimilar CT-P10 was submitted to EMA on 10 November 2015. This action makes Celltrion the first company in the world to submit an application for approval of a rituximab biosimilar.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.
There is unfortunately no information in what indications Celltrion is seeking approval. There is also no mention of what data were included in the submission.
The originator product, Roche’s MabThera/Rituxan (rituximab) had sales of CHF 5.7 billion (Euros 5.2 billion) in 2014. The patents on MabThera/Rituxan expire in the US in September 2016 and expired in Europe in February 2013 [1].
Celltrion’s infliximab biosimilar (Remsima) was approved by EMA in September 2013 [2] and 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 [3]. Celltrion has also started a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) [4].
Related articles
Biosimilars of rituximab
Celltrion stops phase III trial of biosimilar rituximab
References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20}. 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 © 2015 Pro PharmaCommunications International. All Rights Reserved.
Source: Business Korea
Research
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
General
Humira's resilience in the face of biosimilar competition
Boehringer Ingelheim to expand access to adalimumab biosimilar
Comments (0)
Post your comment