Napp Pharmaceuticals has bagged exclusive rights to distribute Celltrion’s biosimilar of Johnson & Johnson and Merck & Co's anti-inflammatory blockbuster Remicade in the UK.
Remsima, Celltrion’s version of Remicade (infliximab), filed with the US Food and Drug Administration earlier this week, has already been approved by the European Medicines Agency. However Napp will have to wait until the end of February 2015 to market the biosimilar when patents on the branded product expire.
Napp, an independent associate of the Mundipharma group, notes that the therapeutic indications for Remsima are the same as those for Remicade - rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Clinical trials involving over 850 patients in 20 countries and 115 sites were undertaken to demonstrate comparability between the two products.
Paul Schofield, Napp’s medical director, said that “infliximab is already a valuable part of clinicians’ armoury, and the arrival of Remsima, at an anticipated lower price than the originator, should give clinicians the opportunity to treat patients at a lower drugs cost”. In 2012, the NHS spent over £120 million in England alone on Remicade, up 9.5% on the previous year.
Mundipharma and its associates have also secured rights to market Remsima in Germany, Italy, Belgium, Luxembourg and the Netherlands, as well as in the UK.