The first biosimilar versions of Johnson & Johnson’s arthritis drug Remicade have been launched onto the market in Japan and India.
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.
Meanwhile, a biosimilar developed by US biotech Epirus Biopharmaceuticals has been launched in India – its first market – by Ranbaxy Laboratories.
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 drug is sold in Japan by Mitsubishi Tanabe and in other parts of the world by Merck & Co, which together booked around $3bn of the drug’s total sales of more than $8bn in 2013.
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.
The 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.
Epirus said the launch in India has come earlier than expected and represents “an affordable solution for patients and may expand patient access to this important medicine.”
Under the terms of its licensing agreement with Epirus, Ranbaxy also has rights to sell Infimab in other markets in Southeast Asia and North Africa.