The approval represents the seventh marketing authorisation of Celltrion in the country. Credit: © CELLTRION.

The US Food and Drug Administration (FDA) has granted approval for Celltrion‘s Avtozma (tocilizumab-anoh) in both intravenous and subcutaneous formulations as an Actemra biosimilar for treating several conditions.

These include giant cell arteritis, Covid-19, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and rheumatoid arthritis.

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The FDA’s approval is grounded in an evidence totality and comprehensive data package, which includes outcomes from a Phase III global study showcasing Avtozma’s biosimilarity to reference tocilizumab in subjects with moderate to severe active rheumatoid arthritis.

The study met its primary endpoint, demonstrating a comparable change from baseline in disease activity score utilising 28 joints (DAS28)-ESR at week 24.

Final one-year outcomes further backed the biosimilar’s comparability in secondary efficacy, safety, immunogenicity and pharmacokinetics.

Clinical evidence has confirmed that the biosimilar and its reference to tocilizumab are said to be ‘highly similar’, with no clinically meaningful differences in safety, immunogenicity or efficacy.

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This approval represents the company’s seventh marketing authorisation in the country and adds to its portfolio as the company’s fifth immunology biologic.

Celltrion USA chief commercial officer Thomas Nusbickel said: “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 comprises a recombinant humanised monoclonal antibody, tocilizumab, which blocks the interleukin 6 (IL-6) receptor.

Celltrion filed for regulatory approval with the FDA and the European Medicines Agency in January and February last year, respectively, based on the data from the Phase III global trial.

In August last year, the European Commission approved the company’s Stelara biosimilar, SteQeyma, for treating chronic inflammatory conditions.