Celltrion’s CT-P13 (biosimilar, infliximab) Receives CHMP’s Positive Opinion for its SC Formulation to Treat Rheumatoid Arthritis

Celltrion’s CT-P13 (biosimilar, infliximab) Receives CHMP’s Positive Opinion for its SC Formulation to Treat Rheumatoid Arthritis

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