Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Shots:Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the USIn Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for…

ByRidhi RastogiOctober 6, 2025

NEWS

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications 

Shots:  The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA) Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…

ByDipanshu DixitFebruary 24, 2024

NEWS

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…

ByDipanshu DixitJanuary 28, 2024

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications

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

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