Celltrion wins FDA approval for first subcutaneous version of IBD drug infliximab

Published: Oct 24, 2023

By Tristan Manalac


The FDA on Monday approved Celltrion’s subcutaneous formulation of infliximab, now to be marketed under the brand name Zymfentra, for the maintenance therapy of adults with moderate-to-severely active ulcerative colitis and Crohn’s disease.

Zymfentra is the first FDA-authorized subcutaneous formulation of infliximab, according to Celltrion’s announcement. The therapy is indicated for patients who had previously undergone intravenous infliximab treatment.

Infliximab is an IgG1 monoclonal antibody that works by blocking the pro-inflammatory cytokine TNF-alpha, which is known to play a role in driving inflammatory diseases such as ulcerative colitis (UC) and Crohn’s disease (CD). Infliximab was first approved in 1998 and is sold by Johnson & Johnson’s Janssen under the brand name Remicade.

Several Remicade biosimilars have since hit the market, including Amgen’s Avsola and Organon’s Renflexis. Celltrion has its own infliximab biosimilar Inflectra, which was approved in April 2016. Pfizer holds exclusive commercial rights to Inflectra in the U.S. and certain other territories.

Remicade and all of its biosimilars are administered intravenously. Zymfentra, on the other hand, has been reformulated to be available via a subcutaneous injection. Because of this, Zymfentra would be considered a biobetter of Inflectra in international markets.

According to an article in the Generics and Biosimilars Initiative Journal, biobetters are an emerging class of follow-on treatments that “seek superiority in one or various aspects of their clinical profile” versus a known biologic. While biobetters target the same protein, they could have a better structure, include an additional target or function or—as in the case of Zymfentra—come in a different formulation resulting in a better outcome profile.

Celltrion USA CEO Thomas Nusbickel said in a statement that Zymfentra’s approval provides patients an alternative treatment option and gives them greater “control of how and where they receive their treatment.”

However, since biobetters—as a concept and as a regulatory class—have not yet caught on in the U.S., Zymfentra was approved as a novel drug based on its own standalone Biologics License Application.

Celltrion supported this submission with pivotal data from the Phase III LIBERTY-UC and LIBERTY-CD studies, which together demonstrated that maintenance therapy with Zymfentra induced higher rates of clinical remission than placebo in patients with moderate-to-severe UC and CD, respectively, following induction with intravenous infliximab.

In terms of safety, both studies did not record new signals of concern and found that the frequencies of adverse events were similar to that in the placebo group.

Zymfentra will have patent protections for its dosage form until 2037 and route of administration until 2040, according to Celltrion.

Source: BioSpace