Nov 29, 2019: Evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumatoid arthritis, Celltrion has revealed data from its Remsima SC (infliximab) trials.
The European Commission approved this drug for patients with rheumatoid arthritis, marking it as the world’s first approved subcutaneous formulation of infliximab.
Patients with Remsima SC shown to have a stable potency while patients with RA on Remsima SC develop fewer anti-drug antibodies – which leads to improve the effectiveness of a treatment – compared with those on CT-P13 IV.
On the 19th September of this year the European Medicines Agency’s (EMA) human medicines committee (CHMP) issued an optimistic opinion for the subcutaneous version of the drug, also known as CT-P13, as a line extension, and the data from that trials was submitted to the EMA as part of the application.
Celltrion has also announced the submission a advance variation to the marketing authorisation of Remsima SC, to extend the indication in inflammatory bowel disease with the approval decision expected in mid-2020. https://www.celltrionhealthcare.com/en-us/board/newslist