Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.
Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency (EMA).
The drug maker explained that it has been conducting phase 1 and phase 3 studies of the subcutaneous-administration formulation of the drug since 2016 as part of a “twin track” development procedure alongside its development of the already-approved infused product.
During the 2018 European League Against Rheumatism's Annual European Congress of Rheumatology, researchers reported in an abstract that the subcutaneous presentation of the biosimilar, which can be self-administered by the patient, had similar efficacy and generally similar safety to the currently approved intravenous CT-P13 in patients with rheumatoid arthritis (RA).1
Separately, the company announced positive results from a phase 1 study comparing the subcutaneous formulation to the approved formulation in patients with Crohn disease, and the study’s authors wrote that pharmacokinetic and pharmacodynamic modeling based on the comparable efficacy and safety results in the study suggest that the subcutaneous and intravenous doses of CT-P13 are similar.2
Celltrion said in a statement to the press that it believes patients who are currently receiving other subcutaneously administered biologics—such as adalimumab or etanercept—could be incented to change their treatment to biosimilar infliximab if offered the subcutaneous formulation.
The company plans to submit its application to the EMA by the end of the year.
1. Westhovens R, Yoo DH, Jaworski J, et al. Novel formulation of CT-P13 for subcutaneous administration in patients with rheumatoid arthritis: initial results from a phase i/iii randomised controlled trial. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract THU0191. doi: 10.1136/annrheumdis-2018-eular.1810.
2. Schreiber S, Jang BI, Borzan V, et al. Novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: initial results from a phase 1 open-label randomized controlled trial in patients with active Crohn’s disease. Gastroenterology. 2018;154(6):S-1371. doi: 10.1016/S0016-5085(18)34477-9.