Subcutaneous form of infliximab biosimilar recommended for EU approval
medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended subcutaneous CT-P13, an infliximab biosimilar, for approval in Europe.
The new subcutaneous form of CT-P13 will only be authorized for the treatment of rheumatoid arthritis (RA), unlike the existing intravenous forms of infliximab and CT-P13, which are approved for patients with various rheumatic diseases including RA, psoriatic arthritis, and ankylosing spondylitis. Approval of the subcutaneous form was based on the results of a study demonstrating similar efficacy and safety profiles of subcutaneous and intravenous CT-P13 in people with RA.
The EMA says that subcutaneous CT-P13 should be used in combination with methotrexate for the treatment of patients with active RA and an inadequate response to conventional DMARDs, or those with severe, active, and progressive disease not previously treated with DMARDs.
The new form of the biosimilar will be available as a 120 mg solution in prefilled pens or syringes for subcutaneous injection.
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