The subcutaneous drug is already approved for ulcerative colitis and Crohn’s disease in Europe. Image credit: Shutterstock/Emily frost.

The US Food and Drug Administration (FDA) has approved Celltrion USA’s Zymfentra (infliximab-dyyb) for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Zymfentra is a subcutaneously administered version of Celltrion USA’s Remsima, a biosimilar of Janssen’s Remicade (infliximab). Janssen is a subsidiary of Johnson & Johnson. Remsima was approved in Europe in September 2013, becoming the first monoclonal antibody biosimilar in the world to win approval. In April 2016, the FDA approved the drug under the name Inflectra.

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Celltrion USA already has a subcutaneous infliximab product in Europe under the name Remsima SC. The drug is approved for the treatment of ulcerative colitis and Crohn’s disease, in addition to rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis.

Celltrion USA currently has five FDA-approved biosimilars: Truxima (rituximab-abbs), Herzuma (trastuzumab-pkrb), Vegzelma (bevacizumab-adcd), Yuflyma (adalimumab-aaty), and Inflectra (infliximab-dyyb).

The FDA based its decision on data from two separate Phase III trials investigating the drug’s efficacy compared to placebo in patients with ulcerative colitis (NCT04205643) and Crohn’s disease (NCT03945019), respectively. Results from the trials, which enrolled a combined 781 patients, demonstrated greater clinical remission rates in patients treated with Zymfentra compared to placebo, based on a 22 October company press release.

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Zymfentra, like Remicade, is an anti-tumour necrosis factor (TNF) antibody. High levels of TNF are associated with immune-mediated inflammatory diseases.

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Celltrion USA has a marketing agreement with Pfizer for the US distribution of Inflectra. A GlobalData consensus forecasts Remsima/Inflectra to have annual global sales of $2.36bn in 2029.

GlobalData is a parent company of Pharmaceutical Technology.

On 23 October, Celltrion Group announced the shareholder approval of a merger agreement between Celltrion, Inc and Celltrion Healthcare, bringing its businesses under one roof.

Update: An earlier version of this article referred to Zymfentra as a Remsima biosimilar due to an editing error. The headline and standfirst were updated on 26 October.