Shots:

• The EMA’s CHMP has adopted the positive opinion for CT-P13 SC for its MAA which is based on P-I/III study assessing PK- safety & efficacy of CT-P13 SC vs its IV formulation in patients with active RA
• The P-I/III study results demonstrated non-inferiority in efficacy of CT-P13 SC to CT-P13 IV @30wks. with similar DAS28- ACR20- ACR50- ACR70 scores and EULAR-CRP response and showed comparable safety profile
• CT-P13 SC is the subcutaneous version of Remsima (biosimilar infliximab)- available with three administration options- i.e- via a pre-filled pen (auto-injector)- pre-filled syringe or pre-filled syringe with needle safeguard- being evaluated in ongoing P-III study for IBD

Click here to­ read full press release/ article | Ref: Business wire | Image: Celltrion