Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.
After having received Complete Response Letters (CRL) in April 2018 for 2 proposed biosimilars, Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application (BLA) for CT-P6, a trastuzumab molecule referencing Herceptin. Last month, the company resubmitted its BLA for CT-P10, a rituximab biosimilar referencing Rituxan.
According to a statement on Celltrion’s website, the FDA requested supplementary information about both products when it issued the CRLs, and the company worked closely with regulators to address issues identified in a February 2018 FDA warning letter related to manufacturing processes. In today's announcment about trastuzumab’s resubmission, Celltrion indicated that the FDA has notified the company of its reinspection schedule, and both molecules could potentially be approved by the FDA by the end of 2018.
Separately, Celltrion also announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13 (sold in the United States as Inflectra and in the European Union as Remsima). During the European League Against Rheumatism's Annual European Congress of Rheumatology, held last week in Amsterdam, Netherlands, researchers reported that the company’s subcutaneous CT-P13, which can be self-administered, had similar efficacy and generally similar safety to the currently approved intravenous CT-P13 up to week 30 in patients with rheumatoid arthritis (RA).1
In a study of 48 patients with RA, who were assigned to receive either the intravenous infliximab or subcutaneous injections of 90 mg, 120 mg, or 180 mg of infliximab, disease improvement (assessed in terms of disease activity score in a count of 28 joints and the American College of Rheumatology’s criteria for 20% improvement) was comparable across all 4 treatment groups, regardless of route of administration or dosage.
Two patients experienced hypersensitivity reactions, and 1 of the 2 tested positive for anti-drug antibodies at week 6.
Earlier this month, Celltrion reported positive results from a phase 1 study of its subcutaneous formulation of the biosimilar in patients with Crohn disease. In that study, patients who received intravenous therapy and those who received subcutaneous doses of 120 mg, 180 mg, and 240 mg showed similar improvement in terms of Crohn Disease Activity Index score.
Currently, there are no subcutaneous infliximab options available to patients with inflammatory diseases; a self-administered option, if eventually approved, could allow patients greater flexibility in their treatment options for these diseases.
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.