Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra)
Shots:
- The US FDA has approved Avtozma (biosimilar, Actemra) for treating diseases such as RA, GCA, pJIA, sJIA, and COVID-19
- Approval was based on P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.24 & with 1-year results with no clinical differences in efficacy, PK, safety, and immunogenicity
- Avtozma (SC/IV) is a recombinant humanized mAb that targets the IL-6 receptor. The IV infusion is available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL (20 mg/mL), while SC in 162 mg/0.9 mL single dose prefilled syringe or autoinjector
Ref: Prnewswire | Image: Celltrion
Related News:- The US FDA Grants Approval to Celltrion's Steqeyma (Biosimilar, Stelara)
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