Celltrion's Remsima SC (biosimilar- infliximab) Receives EC's Approval for Rheumatoid Arthritis
Shots:
- 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: Celltrion
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com