Advisors to the US Food and Drug Administration will meet next month to review Celltrion’s biosimilar of Johnson & Johnson and Merck & Co’s anti-inflammatory blockbuster Remicade.
The FDA’s Arthritis Advisory Committee will gather on March 17 to discuss the South Korean-based group’s Remsima, its version of Remicade (infliximab). The filing, in August, was the first for a monoclonal antibody using the agency’s new biosimilar pathway.
Celltrion is seeking to get approval for Remsima in the same therapeutic indications as 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 have been undertaken to demonstrate comparability between the two products.
Remsima, which has already been approved by the European Medicines Agency, will be co-marketed by Hospira (set to be acquired for $17 billion by Pfizer) on both sides of the Atlantic.
