FDA votes 21-3 in favour of Remicade biosimilar; Pfizer preps for 2016 launch
Yesterday the US Food and Drug Administration (FDA) Arthritis Advisory Committee voted 21-3 in favour of recommending the biosimilar CT-P13 for approval across all the same indications as Janssen’s reference biologic, Remicade (infliximab).
“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,” Celltrion’s CEO HyoungKi Kim said, following the vote.
If approved, the biosimilar will be marketed in the US by Pfizer (which acquired Celltrion’s commercialisation partner Hospira last year), which commended the FDA panel’s recommendation in a statement yesterday.
“We look forward to the FDA’s continued review and, while awaiting its decision and certain other factors, we are moving ahead with the preparation of our launch plans for 2016,” said Jenny Alltoft, global biosimilars lead at Pfizer.
A pre-release document had revealed the biosimilar – marketed as Remsima/Inflectra in Europe – to be “highly similar” but had left questions open to which of Remicade’s seven indications, on top of rheumatoid arthritis (RA), Celltrion’s product would be recommended for.
Extrapolation
In Europe extrapolation to all indications has been approved, while in Canada and Israel extrapolation to the inflammatory bowel disease (IBD) indications - Crohn’s disease and ulcerative colitis - has not been granted.
Jay Siegel, Chief Biotechnology Officer at Johnson & Johnson, was disappointed with the FDA panel’s decision.
“We believe that the data to date, absent of direct comparisons of CT-P13 and REMICADE in patients with inflammatory bowel disease, leave uncertainty about whether differences in safety or efficacy may emerge for patients,” he said.
“We appreciate the discussions at today’s hearing, and note that some of the advisors—who voted on either side of the question—share our concerns regarding residual uncertainty about the use of CT-P13 in IBD.”
