New Biosimilar Autoimmune Disease Treatment Approved by FDA

Celltrion’s Avtozma (tocilizumab-anoh), a biosimilar to Actemra (tocilizumab), in both intravenous (IV) and subcutaneous (SC) formulations, has been approved by the U.S. Food and Drug Administration. Avtozma, formerly known as CT-P47, is an interleukin-6 receptor antagonist indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to ne or more disease-modifying anti-rheumatic drugs; adults with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis; and hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Approval was based on a Phase III study that demonstrated the product is highly similar to Actemra. The trial evaluated the efficacy and safety of tocilizumab-anoh with reference tocilizumab (r-TCZ) in 471 patients with moderate to severe active rheumatoid arthritis. Study participants were randomly assigned 1:1 to receive tocilizumab-anoh or r-TCZ intravenously every four weeks through week 20 in the first treatment phase. In the second treatment phase prior to week 24, those who received r-TCZ were re-randomized to either maintain treatment or switch to tocilizumab-anoh until week 48. The coprimary endpoints were the mean change from baseline in disease activity score 28 using erythrocyte sedimentation rate (DAS28-ESR) at week 12 and week 24. 

Findings showed the estimated treatment differences in DAS28-ESR were -0.01 and -0.10 at week 12 and 24, respectively. Additionally, comparable pharmacokinetics, safety and immunogenicity were observed between the biosimilar and reference product. There was also sustained efficacy and no safety issues when switching from r-TCZ to tocilizumab-anoh. 

“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.”