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Find Clinical Drug Pipeline Developments & Deals for Infliximab
Remsima (infliximab) blocks the action of TNF-alpha. It is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis and crohn’s disease.
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.
Under a prior Memorandum of Understanding, the anti-TNF infliximab, Remsima (a biosimilar of Remicade), approved for use in the U.K., will be supplied for trial by Celltrion Healthcare UK Limited. The University of Oxford and Celltrion are currently completing contract terms.
Formulating infliximab as an oral capsule – which must survive the digestive system's harsh environment and reach the colon intact – is transformational.
Results Remsima (infliximab), showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate.
Data from the RTDM study show infliximab drug levels are stable across a 14-day treatment cycle for Crohn’s disease patients in remission, under maintenance therapy with Remsima SC, enabling therapeutic drug monitoring to be performed at any time between the two SC injections.
Under the MOU with Celltrion Healthcare, supply of anti-TNF biosimilar drug used in the ongoing development for new indications including the first antibody biosimilar, Remsima®, infliximab for major autoimmune disorders such as rheumatoid arthritis and ulcerative colitis.
Remsima™ SC is the first and only subcutaneous form of infliximab to patients, payers and clinicians in Canada. Remsima™ SC offers an innovative treatment option for patients living with chronic inflammatory conditions in Canada.
The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading.
The three drugs are Janssen’s infliximab (Remicade), Bristol Myers Squibb’s (BMS) abatacept (Orencia) and AbbVie’s investigational late-stage drug Cenicriviroc (CVC).
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