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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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