Shots:
- Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the US
- In 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 its IV formulation to treat pts (≥2yrs.) with cytokine release syndrome
- Avtozma IV is a recombinant humanized mAb that targets the IL-6 receptor & is available in 80mg/4mL, 200mg/10mL, & 400mg/20mL (20 mg/mL) in single-dose vials
Ref: Celltrion | Image: Celltrion| Press Release
Related News:- Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)
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