Medication company Celltrion Healthcare reported on Monday the receipt of approval from the European Commission for Remsima SC ((CT-P13 SC, biosimilar infliximab) for the treatment of patients with rheumatoid arthritis in combination with methotrexate (MTX).
The company said Remsima SC, which is the world's first subcutaneous formulation of infliximab, is approved in the EU for treating rheumatoid arthritis in combination with methotrexate (MTX), when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate as well as in adult patients with severe, active and progressive disease not previously treated.
This EU approval is based on clinical evidence from the company's study that showed switching people with RA from the intravenous (IV) formulation to the subcutaneous (SC) formulation of CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile). The study was presented at this year's American College of Rheumatology Congress.
Remsima SC's novel formulation provides an alternative administration option for European physicians and their patients. CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications, stated the company.
Additionally, the company has applied for patent protection until 2038 for Remsima SC in 100 countries in the US, Europe and Asia.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial