Celltrion’s Remsima SC (infliximab, CT-P13) Receives the EC’s MAA for Additional Five Indications

 Celltrion’s Remsima SC (infliximab, CT-P13) Receives the EC’s MAA for Additional Five Indications

Celltrion Reports Submission of MAA to EMA for CT-P17 (biosimilar, adalimumab)

  • The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety
  • The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
  • Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US, Canada, Japan and throughout EU

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

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.

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