Celltrion’s Actemra (tocilizumab) biosimilar Avtozma (tocilizumab-anoh) has received FDA approval for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) as well as COVID-19.
The approval encompasses both intravenous (IV) and subcutaneous (SC) formulations, offering flexibility in administration.
The approval marks Celltrion’s seventh biosimilar to be granted marketing authorization in the US and its fifth immunology biologic approval.
The FDA’s decision was based on comprehensive data demonstrating biosimilarity between Avtozma and the reference product, Actemra.
A pivotal Phase III study involving patients with moderate to severe active RA met its primary endpoint, showing comparable efficacy, safety, pharmacokinetics and immunogenicity profiles between Avtozma and Actemra.
Avtozma is the third FDA-approved biosimilar to Actemra. In September 2023, Biogen’s IV formulation Tofidence (tocilizumab-bavi) was the first Actemra biosimilar to receive FDA approval, followed by the approval of Fresenius Kabi’s Tyenne (tocilizumab-aazg) in both IV and SC formulations in March 2024.
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Actemra, originally approved for RA and other inflammatory conditions, was authorized for emergency use as a COVID-19 treatment due to its ability to reduce severe inflammation caused by the virus. Its primary patents expired back in 2015 in the US and the European Union (EU).
In June 2021, the FDA granted emergency use authorization (EUA) for Actemra to treat hospitalized COVID-19 patients. That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19. It also has EUA for children aged between two and 18.
Avtozma will be available in the same formulations and dosages as the reference product. The IV infusion is provided in 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL) and 400 mg/20 mL (20 mg/mL) vials. The SC injection comes in 162 mg/0.9 mL single-dose prefilled syringes or autoinjectors.
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“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 in a statement from the company.
“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.”
Avtozma is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist that works by targeting specific inflammatory proteins to dampen immune responses.
Avtozma was submitted for regulatory approval to the FDA in January 2024 and the European Medicines Agency (EMA) in February 2024.
Celltrion has not disclosed the pricing of Avtozma yet.
According to a Genentech spokesperson cited by Formulary Watch last year, the average monthly cost of Actemra administered via IV ranges from approximately $2,308 to $4,616, depending on the dosage. For subcutaneous administration, the cost ranges from about $2,478 to $4,956, varying based on the patient’s weight and dosing frequency.
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