FDA Panel Recommends Approval of Remicade Biosimilar
The drug is the first biosimilar monoclonal antibody to be considered by the FDA.
An FDA advisory committee has recommended approval to a biosimilar of Johnson & Johnson’s arthritis drug infliximab (Remicade).
The drug is the first biosimilar monoclonal antibody (mAb) to be considered by the FDA. The Arthritis Advisory committee recommended approval of all indications for the biosimilar named CT-P13.
"Our CT-P13 application in the US is the first in an age where biosimilar mAbs are globally recognized as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable for patients," said CEO of Celltrion, HyoungKi Kim.
The recommendation followed evidence that showed similar results in safety, potency, and purity between Celltrion and Pfzier Inc’s CT-P13 and Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and other autoimmune diseases.
The panel also found CT-P13 likely has a similar safety and efficacy profile for the same indications as Remicade, which includes psoriasis, Crohn's disease and ulcerative colitis, despite the fact that CT-P13 was not evaluated for those conditions, according to Reuters.
These results were presented at the Arthritis Advisory Committee meeting.
"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," Kim said. "We have experienced the benefits of biosimilars outside of the US, including Europe, and are looking forward to advancing our development program with the FDA.”
The FDA decision is expected to come in April 2016. If it is approved, Pfizer would gain the commercialization rights for CT-P13 under the proposed brand name Inflectra, according to Celltrion.