FDA Approves Third Biosimilar of Actemra

The FDA has approved Celltrion’s similar of Genentech’s Actemra (tocilizumab). Celltrion’s Avtozma (tocilizumab-anoh) will be available as both an intravenous (IV) and subcutaneous (SC) formulations to treat patients with rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis and COVID-19.

Avtozma pricing will be finalized closer to the commercial launch as the company continues to engage with stakeholders, including payers and healthcare providers, according to a company spokesperson.

The FDA's decision is based on the totality of evidence, including the results from a phase 3 study demonstrating biosimilarity between Avtozma and reference tocilizumab in patients with moderate to severe active rheumatoid arthritis. The primary endpoint was met in terms of change from baseline in disease activity score and the final one-year results supported comparability in secondary efficacy, pharmacokinetic, safety and immunogenicity results between Avtozma and reference tocilizumab.

Avtozma is Celltrion's seventh biosimilar granted marketing authorization in the United States and is the third biosimilar of Actemra to be approved by the FDA. Fresenius Kabi’s Tyenne (tocilizumab-aazg) in both IV and SC formulations was approved in March 2024, and in September 2023, the FDA approved Biogen’s IV formulation biosimilar, Tofidence.

Actema and the three biosimilars are interleukin-6 (IL-6) receptor antagonists that target specific inflammatory proteins to suppress the immune system.

The average monthly cost of Actemra administered via IV ranges from about $2,308 to $4,616, depending on which dose a person receives, a Genentech spokesperson told Formulary Watch last year. The average monthly cost of Actemra administered subcutaneously ranges from about $2,478 to $4,956 depending on how frequently a person takes it, the dose varies depending on the person’s weight.

Biosimilars have generated $36 billion in savings since 2015, according to a September 2024 report from the Association for Accessible Medicines. In 2023 alone, savings from biosimilars was $12.4 billion.