FDA approves third Actemra biosimilar; second available in intravenous, subcutaneous forms
The FDA has approved a third biosimilar for tocilizumab, called Avtozma, the second such biosimilar to be available in both intravenous and subcutaneous formulations, according to a press release.
Avtozma (tocilizumab-anoh, Celltrion) is approved for the treatment of multiple autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, and both polyarticular and systemic forms of juvenile idiopathic arthritis, as well as COVID-19.
Tocilizumab (Actemra, Genentech) is a recombinant humanized monoclonal antibody and IL-6 receptor antagonist.
The FDA’s decision was informed by phase 3 study results, presented at ACR Convergence 2024, showing biosimilarity in patients with moderate-to-severe RA. Patients treated with Avtozma met the primary endpoint — improvement from baseline DAS28 with erythrocyte sedimentation rate — at week 24, and results continued supporting the comparability of the drugs out to 1 year.
Avtozma is the second tocilizumab biosimilar available in intravenous and subcutaneous forms, following the March approval of Tyenne (tocilizumab-aazg, Fresenius Kabi). Both formulations will follow the same dosages as the originator: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20mL for IV infusion, and 162 mg/0.9 mL for injection with a single-dose syringe or autoinjector.
The availability of both formulations will provide physicians and patients with “flexibility and a wider range of treatment options, allowing tailored treatment based on individual needs and preferences,” Thomas Nusbickel, chief commercial officer at Celltrion USA, told Healio.
“This approval represents a strategic addition to Celltrion’s immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and health care providers,” he added.
Nusbickel stated he was unable to disclose when the biosimilar will be available in the United States.
“In accordance with the patent settlement agreement with the originator, Celltrion has a license to market Avtozma in the United States starting from the license dates, which remain confidential at the moment,” he said.