Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US
Shots:
- Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market
- Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional Jul 2025 FDA approval for its IV formulation to treat pts (≥2yrs.) with cytokine release syndrome
- Avtozma SC is a recombinant humanized mAb that targets the IL-6 receptor & is available in 162mg/0.9mL in a single-dose prefilled syringe or a single-dose prefilled autoinjector
Ref: Celltrion | Image: Celltrion | Press Release
Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea
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