Celltrion USA, the American subsidiary of the biopharmaceutical company Celltrion, has filed a biologics licence application (BLA) with the US Food and Drug Administration (FDA) for its biosimilar candidate CT-P47.

CT-P47 is a biosimilar candidate of the reference product ACTEMRA (tocilizumab).

The application sought approval for the drug to treat moderate to severe active rheumatoid arthritis.

The BLA for CT-P47 is supported by data from an international Phase III clinical trial.

The trial assessed the pharmacokinetics, safety, efficacy and immunogenicity of CT-P47 versus ACTEMRA in patients with rheumatoid arthritis who had an inadequate response to methotrexate.

ACTEMRA is currently approved for indications including adult rheumatoid arthritis and juvenile idiopathic arthritis conditions.

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Celltrion is seeking approval for intravenous and subcutaneous administration routes for CT-P47.

Founded in 2018, Celltrion USA aims to increase the availability of innovative biologics in the US healthcare market.

The company plans to use Celltrion’s expertise in biotechnology, supply chain management and sales to enhance the accessibility of high-quality biopharmaceuticals for patients in the US.

Celltrion has a presence in 110 countries, offering cost-effective biopharmaceutical solutions.

The FDA approved Celltrion USA’s Zymfentra as maintenance therapy in adults with ulcerative colitis and Crohn’s disease in October 2023.

Zymfentra, a subcutaneous version of Celltrion USA’s Remsima, is a biosimilar to Janssen’s Remicade (infliximab).

Remsima gained approval in Europe in September 2013 as the world’s first monoclonal antibody biosimilar and was approved by the FDA in April 2016 under the name Inflectra.

Celltrion USA chief commercial officer Thomas Nusbickel stated: “The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden.

“We plan to lead the market by establishing a diverse product line-up in the autoimmune disease market in the US.

“We will continue to actively co-operate with the FDA’s review in an effort to bring this new treatment option to people living with rheumatoid arthritis as soon as possible.”