South Korean biotechnology company Celltrion announced on 4 and 16 July 2014 that the company had received marketing approval for its biosimilar Remsima (infliximab) in Japan and Turkey, respectively.
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics major Hospira [1]. Since then, Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3].
The Japanese approval of Remsima has taken less than a year. Celltrion filed for approval of Remsima with Japan’s Ministry of Health, Labour and Welfare (MHLW) on 11 September 2013 [4]. The product, which is the first monoclonal antibody biosimilar to be approved in Japan, was developed in collaboration with Japanese pharma firm Nippon Kayaku.
Japan is the second largest pharmaceutical market after the US. During 2013, sales of the originator drug (Remicade) in Japan totalled approximately South Korean Won 1 trillion.
The Ministry of Health in Turkey (MoH) granted marketing approval for Remsima for the treatment of rheumatoid arthritis, ankylosing spondilitis, Crohn’s disease, ulcerative colitis, psoriasis and psoriatic arthritis. Celltrion submitted its application for Remsima approval to the Turkish Medicines and Medical Devices Agency on 9 April 2013. Celltrion plans to launch Remsima into the Turkish market beginning in the fourth quarter of 2014.
Turkey is the sixth largest pharmaceutical market in Europe and the 16th largest pharmaceutical market in the world. Celltrion estimates the potential market size for Remsima to be approximately US$150 million, based on sales of tumour necrosis factor (TNF)-α inhibitor in the country.
With these latest approvals, Celltrion estimates that it now has access to sales of roughly half of the entire market for the originator drug (Remicade). The company is also anticipating submitting marketing authorization approval for Remsima in the US in the latter half of 2014.
Editor’s comment
It should be noted that ‘biosimilars’ approved in Turkey might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan
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