FDA advisory panel backs approval of Celltrion's Remicade biosimilar

As was widely expected follow positive staff briefing papers ahead of the hearing (The Pharma Letter February 6), the US Food and Drug Administration Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech's Remicade (infliximab), by a vote of 21-3.

CT-P13 is the first biosimilar monoclonal antibody (MAb) medication to be considered by the FDA. South Korean firm Celltrion’s (Kosdaq: 068270) is seeking approval of CT-P13 for the treatment of a variety of serious autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis, among others. CT-P13, which is already approved in Europe and some other markets under the trade name Remsima, is partnered with US pharma giant Pfizer (NYSE: PFE). If approved by the FDA, Pfizer would assume commercialization rights for the medication in the USA under the proposed brand name, Inflectra. The FDA’s decision is anticipated in April 2016.

The Committee based its recommendation on the totality of evidence presented at the Arthritis Advisory Committee meeting on Tuesday, comparing CT-P13 to the US reference product, Remicade, in which the Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components. Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and US-licensed Remicade in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis. The Committee acknowledged the extensive data provided by Celltrion to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use.