FDA Approves Celltrion's AVTOZMA, a Biosimilar to ACTEMRA

JERSEY CITY, NJ, USA I January 30, 2025 I Celltrion has revealed that the U.S. Food and Drug Administration (FDA) has given its approval for AVTOZMA (CT-P47, tocilizumab-anoh) as a biosimilar to ACTEMRA. This approval includes both intravenous (IV) and subcutaneous (SC) formulations. AVTOZMA is designed for addressing various medical conditions: rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19.

Thomas Nusbickel, the Chief Commercial Officer at Celltrion USA, emphasized that the introduction of dual formulations for AVTOZMA enhances treatment flexibility and broadens options for patients. He highlighted that this approval marks a significant enhancement of their immunology portfolio and underscores Celltrion's commitment to providing accessible, high-quality treatment options. The aim is to ensure these alternatives are safe and effective, allowing healthcare providers and plan sponsors to meet the needs of diverse patient groups effectively.

The FDA's approval is grounded in a comprehensive data review, including a phase III study that confirmed AVTOZMA's biosimilarity to reference tocilizumab in individuals with moderate to severe RA. The trial achieved its primary endpoint by demonstrating a change in disease activity score using 28 joints (DAS28-ESR) at the 24-week mark. The study's one-year results affirmed that AVTOZMA and the reference tocilizumab are comparable in terms of secondary efficacy outcomes, pharmacokinetics (PK), safety, and immunogenicity, exhibiting no significant clinical differences between the two.

As per a patent agreement with Genentech, the IV formulation of AVTOZMA is anticipated to enter the U.S. market in August 2025. Meanwhile, Celltrion is licensed to market the SC version starting from the date of license, although this date remains undisclosed. AVTOZMA represents Celltrion's seventh biosimilar to receive marketing clearance in the United States.

AVTOZMA, containing tocilizumab, functions as an interleukin 6 (IL-6) receptor antagonist. It is developed as a recombinant humanized monoclonal antibody. The global Phase III clinical trial aimed at evaluating AVTOZMA's efficacy, pharmacokinetics, safety, and immunogenicity compared to reference tocilizumab. Regulatory approvals were sought from the FDA and the European Medicines Agency (EMA) in early 2024.

Regarding safety, AVTOZMA carries a warning about an increased risk of serious infections, potentially resulting in hospitalization or death, especially for patients on concurrent immunosuppressants. If a severe infection occurs, AVTOZMA treatment should be halted until the infection is managed. Other serious concerns include gastrointestinal perforations, hepatotoxicity, changes in laboratory parameters, and hypersensitivity reactions. It's crucial to monitor patients for infection signs, including tuberculosis, during and after treatment.

Celltrion, headquartered in Incheon, South Korea, is a prominent biopharmaceutical company focused on developing, manufacturing, and distributing innovative treatments globally. With a robust network covering over 110 countries, Celltrion aims to deliver high-quality, cost-effective therapeutic solutions. The company has successfully obtained approval for seven biosimilars in the U.S., including AVTOZMA, which now joins Celltrion's expanding portfolio of approved biosimilars.

 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!