The approval will be based on a clinical trial, which Celltrion conducted in Japan with its partner company, Nippon Kayaku, and which was completed in July 2013.

Remsima is a biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab). Remicade is the most successful tumour necrosis factor (TNF) inhibitor treatment in terms of market share in Japan, with sales of the drug in 2012 of Yen 90 billion. Japan is the second largest market for Remicade following the US.

According to an official from Nippon Kayaku ‘the Japanese approval for Remsima will be good news, not only for patients in Japan who previously had limited access to advanced therapeutics, but also for their families and their healthcare providers.’

Celltrion has already gained approval for Remsima from EMA, as well as from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) [1, 2]. As Remsima has already successfully received approval from EMA, the approval process in Japan is expected to proceed smoothly.

Celltrion expects sales of Remsima in Europe to begin as early as September 2013, with the Japanese launch expected to fall in 2014, as the Japanese approval procedure usually takes around a year.

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EC approves first monoclonal antibody biosimilar

References

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

2.  GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-first-monoclonal-antibody-biosimilars

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