FDA staff express support for Celltrion's biosimilar version of Johnson & Johnson's Remicade

February 5, 2016
Ref: Bloomberg;CNBC;Morningstar;FDA

In documents released Friday ahead of an advisory panel meeting on February 9, FDA reviewers concluded that Celltrion's biosimilar CT-P13 is "highly similar" to Johnson & Johnson's Remicade (infliximab). The agency staff said "the results of the clinical development programme indicate that Celltrion's data support the demonstration of 'no clinically meaningful differences' between CT-P13 and…Remicade in terms of safety, purity, and potency in the indications studied."

In its application to the FDA, Celltrion presented data on the use of CT-P13 in the treatment of rheumatoid arthritis and ankylosing spondylitis, with agency staff indicating that it could be assumed that the biosimilar would also be safe for other indications for which Remicade is approved, including Crohn's disease and ulcerative colitis. Specifically, the agency staff said that they found only "minor differences in clinically inactive components" between Remicade and CT-P13.

Novartis' Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim)‎, which was launched in September last year, remains the only biosimilar to be cleared by the US agency. Meanwhile, the FDA recently accepted Amgen's application requesting approval of ABP 501, a biosimilar version of AbbVie's Humira (adalimumab).