Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis

 Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis

Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis

Shots:

  • CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019
  • The CHMP’s opinion is based on data evaluating the PK, efficacy and safety between CT-P13 SC to CT-P13 IV in people with active CD and UC. Part 1 of the study showed overall clinical response as assessed by CDAI-70 with similar scores, clinical remission was high in the SC cohorts with comparable safety profile @54wks.
  • The CHMP has recommended the 120 mg fixed dose of Remsima SC in adults regardless of the body weight, in both existing and newly added indications

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post