Celltrion will have to wait longer than expected for FDA’s Advisory Committee to review its application for Remsima, a biosimilar for Johnson and Johnsons’ Remicade (infliximab). Yesterday, FDA announced that they would be postponing the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015 where they were going to review the product.
View FDA’s announcement here.
“The postponement is due to information requests pending with the sponsor of the application. A future meeting date will be announced in the Federal Register,” states the Agency.
The Advisory Committee was set to review nine proposed indications for Remsima, including treatment of symptoms for Crohn’s disease, rheumatoid arthritis, and plaque psoriasis.
Celltrion’s product, being a monoclonal antibody, is more complex than the Sandoz filgrastim biosimilar for which FDA advisers gave a positive recommendation for all five indications in January of this year. The additional data required to show biosimilarity to a monoclonal antibody perhaps may be a reason for the hold-up.
Celltrion has already obtained approval for Remsima from over 50 countries worldwide, including Europe, Canada and Japan.
Just yesterday, Celltrion announced the launch of Remsima in 12 European markets through a partnership with Hospira. Those countries include Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK.
The U.S. may be a ways off.