Celltrion Reports Results of Remsima SC (biosimilar, infliximab) in a Clinical Study for Active Crohn’s Disease and Ulcerative Colitis #ECCO2020

Shots:

• The clinical study involves assessing the PK, efficacy, and safety of CT-P13 SC vs CT-P13 IV in 131 patients with active CD & UC for 1yr. Following loading doses of IV 5mg/kg @0 & 2wks., patients were randomized @6wks. to receive either SC 120/240 mg q2w or continued IV 5 mg/kg q8w, @30wks. IV arm switched to SC arm based on body weight
• The clinical study results demonstrated that Remsima SC is comparable to its IV formulation @1yr., improvement in clinical activity, rate of clinical response and remission are maintained, improvement in the rate of clinical healing
•  Remsima SC (CT-P13 SC) is the first & only SC infliximab to be available in EU with its expected approval in EU for IBD in mid-2020 and has received EMA’s MAA for RA in H2’19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: PRO EXPO