The US Food and Drug Administration’s Arthritis Advisory Committee is backing the approval of Pfizer and Celltrion’s CT-P13, a biosimilar to Janssen Biotech's blockbuster Remicade.
The drug, which targets a variety of autoimmune diseases includes Crohn’s disease and ulcerative colitis, is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA.
The Committee agreed that data submitted by Celltrion shows that CT-P13 (infliximab) is highly similar to Remicade, and that there were no clinically meaningful differences between the medicines in terms of the safety, purity, and potency in the studied indications of rheumatoid arthritis and ankylosing spondylitis.
"Given that this would be the first biosimilar monoclonal antibody to be approved in the US, this Advisory Committee meeting is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments," said HyoungKi Kim, Celltrion’s chief executive.
"Our CT-P13 application in the US is the first in an age where biosimilar mAbs are globally recognised as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable for patients," he noted.
If approved by the regulator, Pfizer will assume commercialisation rights for the US under the proposed brand name Inflectra. The FDA’s decision is anticipated in April.
Inflectra is already on the European market, where it is sold by Pfizer unit Hospira UK. The same biosimilar, also manufactured by Celltrion, is also sold in the region under the brand name Remsima by Napp.