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Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

Shots :

  • Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study   
  • The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to wk. 52 
  • CT-P47 is a recombinant humanized mAb which targets interleukin 6 (IL-6) receptor indicated for treating rheumatoid arthritis 

Ref: Coherus Biosciences & Sandoz | Image: Coherus Biosciences & Sandoz| Press Release

Related News:- Coherus BioSciences to Divest its Ophthalmology Franchise to Sandoz for $170M Up Front 

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