Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)
Shots:
- The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US
- Approval was based on the 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
- Celltrion has commercialization rights of Avtozma SC formulation in US. Avtozma is a recombinant humanized mAb that targets the IL-6 receptor
Ref: Prnewswire | Image: Celltrion
Related News:- Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra)
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