- The approval is based on P-I/III study assessing PK, efficacy and safety of Remsima/CT-P13 SC + MTX vs CT-P13 IV in patients with active RA with inadequate response to DMARDs, results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks.
- The approval provides patients an opportunity of self-administration to control their own treatment. Remsima SC develops fewer anti-drug antibodies leading to an improvement in treatment for patients with RA
- Remsima SC is the world’s first SC formulation of infliximab and has received CHMP’s positive opinion with its submission of MAA to EMA for extending its indication to IBD, a decision expected in mid-2020. Celltrion plans to launch Remsima SC across EU in Q1’20
Click here to read full press release/ article | Ref: PRNewswire | Image: Reuters