FDA approves Avtozma (tocilizumab-anoh) as biosimilar to Actemra

On January 30, 2025, the U.S. Food and Drug Administration (FDA) officially approved the intravenous (IV) and subcutaneous (SC) dosage forms of Avtozma (CT-P47, tocilizumab-anoh) as a biosimilar to Actemra. This approval provides new options for the treatment of multiple diseases, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and coronavirus disease (COVID-19). The launch of Avtozma, particularly its IV and SC formulations, provides greater flexibility, allowing patients to choose the appropriate dosing method for their condition.

The FDA approval demonstrates a commitment to strategic expansion of the immunology portfolio to provide patients and healthcare providers with accessible, high-quality treatment options. The decision was based on a comprehensive data package and evidence, including results from a Phase III study demonstrating the biosimilarity of Avtozma to the reference drug tocilizumab in patients with moderately to severely active RA.

Theprimary endpoint of the Phase III study is change from baseline using the 28-joint Disease Activity Score (DAS28-ESR) at week 24. Final results showed that secondary efficacy, pharmacokinetics (PK), safety and immunogenicity results between Avtozma and reference tocilizumab were comparable. These clinical results show that Avtozma is highly similar to its reference drug in terms of efficacy, safety, pharmacokinetics and immunogenicity, and there is no clinically meaningful difference.

Avtozma will be available for intravenous and subcutaneous injection, and its dosage form and dosage will remain consistent with the reference product. Intravenous infusion dosage forms include 80 mg/4 ml (20 mg/ml), 200 mg/10 ml (20 mg/ml) and 400 mg/20 ml (20 mg/ml), while subcutaneous injection is available as 162 mg/0.9 ml in single-dose prefilled syringes or single-dose auto-injectors. The intravenous (IV) formulation is expected to be available in the United States in August 2025.

References:https://www.drugs.com/newdrugs/fda-approves-avtozma-tocilizumab-anoh-biosimilar-actemra-6447.html