FDA panel backs approval of Celltrion's biosimilar version of Johnson & Johnson's Remicade

An FDA advisory panel voted 21-3 in support of approval of Celltrion's CT-P13, a proposed biosimilar version of Johnson & Johnson's Remicade (infliximab), for all indications, the Korean drugmaker announced. Celltrion noted that CT-P13, which if approved in the US will be marketed by Pfizer under the brand Inflectra, is the first biosimilar monoclonal antibody to be reviewed by the FDA.

Celltrion is seeking approval of CT-P13 for the treatment of a variety of autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis. Remicade is approved in the US for the treatment of moderately to severely active Crohn's disease in adults and children; moderately to severely active ulcerative colitis in adults and children; moderately to severely active rheumatoid arthritis; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis. For related analysis, see ViewPoints: Extrapolation sensation – FDA panel on board with broad label for Celltrion's Remicade biosimilar.

"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," remarked Celltrion CEO HyoungKi Kim. Last year, the FDA postponed an advisory committee meeting for CT-P13, noting at the time that the delay was due to "information requests pending" with Celltrion. The agency is expected to make a final decision on the filing in April.

"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," remarked Jenny Alltoft, Pfizer's global biosimilars lead. Pfizer has exclusive commercialisation rights to CT-P13 in the US and certain other jurisdictions following its acquisition of Hospira, which had entered a deal with Celltrion in 2009 for several biosimilar products.

Celltrion said that the advisory panel based its recommendation on the totality of evidence comparing CT-P13 to Remicade, with the committee concluding that the data submitted by the Korean company demonstrated that the two drugs are "highly similar...notwithstanding minor differences in clinically inactive components." In addition, the panel noted that there were no "clinically meaningful differences" between CT-P13 and Remicade in terms of the safety, purity and potency of the product in clinical trials in patients with rheumatoid arthritis and ankylosing spondylitis.

However, before the panel vote, Johnson & Johnson's chief biotechnology officer Jay Siegel urged the committee to await results of an ongoing study comparing CT-P13 to Remicade in patients with irritable bowel disease before assuming that the medicines are similar in those conditions. "Only direct clinical comparisons of (CT-P13) and Remicade in active irritable bowel disease can provide the requisite assurance," he said.

Remicade generated global sales of $6.6 billion last year, while revenue from the product in the US reached $4.5 billion. CT-P13 is currently approved in 67 countries including Canada, Japan and throughout Europe, where it was authorised in 2013 and is marketed as Remsima and Inflectra. Wells Fargo analyst Larry Biegelsen expects Celltrion's version to launch in the second-half of 2016 in the US and to reduce sales of Remicade by 10 percent to $4.2 billion by the end of 2017.

For related analysis, see KOL Views: Celltrion's "fascinating" biosimilar AdCom shows that clinicians can be convinced by the concept of biosimilarity, says leading US regulatory expert Gillian Woollett.

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