In Japan, Nippon Kayaku has launched a biosimilar version of Remicade (infliximab) originally developed by South Korean biotechnology company Celltrion, which was approved for marketing in July.
First launched in 1998, Remicade remains one of J&J’s biggest-selling drugs, with sales reaching $3.1bn in the first nine months of the year. In addition to rheumatoid arthritis the tumour necrosis factor (TNF) blocker is also approved to treat psoriasis, Crohn’s disease and ankylosing spondylitis, amongst others.
The turnover has made infliximab a prime target for biosimilar development and Celltrion’s version has already been approved in more than 50 countries, including member states of the EU where it is already being sold in some markets by Celltrion and partner Hospira.
he roll-out of the biosimilar in some of the largest EU markets – notably France, Germany, Italy, Spain and the UK – has been delayed until February next year following an extension to Remicade’s patent protection.
Meanwhile, Celltrion’s product has also been filed in the US, where J&J’s patent protection for infliximab is not due to expire until 2018.
Nippon Kayaku said infliximab is the second biosimilar it has launched to date, having introduced a copycat version of the white blood cell stimulator filgrastim last year. It is the first biosimilar monoclonal antibody to reach the market in Japan.