FDA approves Celltrion's Actemra biosimilar
Celltrion has obtained the Food and Drug Administration's permission for Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous and subcutaneous formulation as a biosimilar to Chugai Pharmaceutical’s Actemra.
Avtozma is indicated for the treatment of multiple diseases including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and coronavirus disease (COVID-19).
"Introducing both IV and SC formulations of Avtozma provides flexibility and a wider range of treatment options," said Thomas Nusbickel, chief commercial officer at Celltrion USA.
[Read more: FDA approves Celltrion's Stelara biosimilar]
Nusbickel added, "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."
Avtozma will be available in both IV and SC formulations, with the same formulation and dosages as the reference product. The IV infusion is provided as 80 mg/4 ml (20 mg/ml), 200 mg/10 ml (20 mg/ml), 400 mg/20 ml (20 mg/ml) and the SC injection comes in 162 mg/0.9 ml in a single-dose prefilled syringe or single-dose autoinjector.
Avtozma is Celltrion's seventh biosimilar granted marketing authorization in the United States.
[Read more: Celltrion USA adds Humira biosimilar to Costco Member Prescription Program]
