FDA approves tocilizumab-anoh as biosimilar for multiple diseases

FDA approves tocilizumab-anoh as biosimilar for multiple diseases | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA recently approved tocilizumab-anoh (Avtozma; Celltrion) as a biosimilar to Actemra (tocilizumab; Genentech) and is indicated for several diseases in both an intravenous and subcutaneous formulations, according to a press release from Celltrion.^1,2

With the federal agency's decision, the biosimilar is indicated for the following¹:

• Plyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older with active pJIA
• Systemic juvenile idiopathic arthritis (sJIA) in patients aged 2 years and older with sJIA
• COVID-19 in hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation
• Giant cell arteritis in adult patients
• Rheumatoid arthritis (RA) in adults with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs

The approval, Celltrion's 7th biosimilar that has been granted marketing authorization in the United States, is based on a comprehensive data package and totality of evidence that included results from a phase 3 study demonstrating biosimilarity between tocilizumab-anoh and reference tocilizumab in patients with moderate-to-severe active RA.

In the trial, the primary endpoint, change from baseline in disease activity score using 28 joints at week 24, was met. In addition, the final 1-year results supported comparability in secondary efficacy, pharmacokinetics, and safety and immunogenicity results between tocilizumab-anoh and the reference.

Results demonstrated that the biosimilar and reference are "highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics and immunogenicity," stated Celltrion in the announcement.

"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. "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."

Tocilizumab-anoh can increase the risk for serious infections, according to a warning from Celltrion, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants.

The biosimilar is contraindicated in those with known hypersensitivity to tocilizumab products.

According to Celltrion, "[tocilizumab-anoh] and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants."

References:

1. US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra. Celltrion. Press release. January 31, 2025. Accessed February 3, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3668

2. Actemra (tocilizumab). Actemra.com. Accessed February 3, 2025. https://www.actemra.com/?adobe_mc=MCORGID%3DDF784CF658BD66380A495D3E%2540AdobeOrg%7CTS%3D1738613567&_gl=1*11kzoh6*_gadup_aw*R0NMLjE3Mzg2MTM1NjguQ2p3S0NBaUE3NEc5QmhBRUVpd0E4a05mcFN6YTl5ckNKa3Vsdjl2UnNVaklEYkVoZ3BHQ2dfNXYxdHpTS29ldnd3X0JtOUF2em9Damh4b0NiU3dRQXZEX0J3RQ..*_gadup_dc*R0NMLjE3Mzg2MTM1NjguQ2p3S0NBaUE3NEc5QmhBRUVpd0E4a05mcFN6YTl5ckNKa3Vsdjl2UnNVaklEYkVoZ3BHQ2dfNXYxdHpTS29ldnd3X0JtOUF2em9Damh4b0NiU3dRQXZEX0J3RQ..*_gadup_ga*MTQyNjQ0OTczOS4xNzM4NjEzNTY4*_gadup_ga_9062X872K9*MjM1OTg1MzgwNDE3NTQ2NC4xLjAuMTczODYxMzU3MC4wLjAuMA.