FDA's committee backs infliximab biosimilar for IBD indications: 4 notes

The FDA's Arthritis Drugs Advisory Committee is backing a medication, which, if approved, would be the first biosimilar monoclonal antibody in the United States, according to a Medscape report.

Here are four notes:

1. The committee voted that the drug, CT-P13, is "highly similar" to the reference product, Janssen Biotech's infliximab, for all of that biologic's approved indications, including for Crohn's disease and ulcerative colitis.

2. CT-P13 is approved in 67 countries, and it is manufactured by Celltrion based in South Korea.

3. Janssen Biotech's infliximab received FDA approval in 1998.

4. The FDA is likely to follow the panel's recommendation. Its decision will come in April.

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