On January 30, the FDA approved Avtozma (tocilizumab-anoh), which was formerly known as CT-P47 by Celltrion. Celltrion will market Avtozma as both intravenous and subcutaneous formulations, in the same dosages as the reference product Actemra.
Avtozma received approval for the following indications:
- Rheumatoid arthritis
- Giant-cell arteritis
- Polyarticular juvenile idiopathic arthritis
- Systemic juvenile idiopathic arthritis
- COVID-19
Actemra has only one indication that Avtozma does not: cytokine-release syndrome related to CAR-T therapy.
In the press release, Thomas Nusbickel, Chief Commercial Officer of Celltrion USA stated, “Introducing both intravenous and subcutaneous formulations of Avtozma provides flexibility and a wider range of treatment options. 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.”
Celltrion now has seven biosimilars approved by the FDA. Celltrion’s Avtozma, an IL-6 inhibitor, was the third tocilizumab biosimilar approved in the United States. This is significant for ensuring adequate competition. There do not seem to be additional tocilizumab biosimilar candidates in the pipeline (or at least not disclosed). Celltrion did not disclose a launch date for Avtozma or its pricing. by the time of publication. At present, the lowest price tocilizumab biosimilar is 35% below the ASP of the reference product.
