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

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Celltrion

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

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  • 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: PR Newswire | Image: Celltrion

Related News:- Celltrion’s Zymfentra (Infliximab-Dyyb) Receives the US FDA’s Approval for the Treatment of Inflammatory Bowel Disease

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Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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