The US Food and Drug Administration (FDA) has approved Celltrion’s intravenous (IV) formulation of Avtozma (tocilizumab-anoh) to treat cytokine release syndrome (CRS) in adults and paediatric patients aged two years and older.
Avtozma IV, a biosimilar referencing Actemra (tocilizumab), received approval from the FDA earlier this year for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved product. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
The regulator’s latest decision means that Avtozma IV now fully aligns with all indications covered by Actemra IV in the US.
CRS occurs when the immune system responds to infection or immunotherapy drugs more aggressively than it should, resulting in inflammation and damage to healthy tissue and organs. The condition is potentially life-threatening, with symptoms ranging from mild and flu-like to more severe complications such as low blood pressure, breathing difficulties and multi-organ failure.
Thomas Nusbickel, chief commercial officer at Celltrion USA, said: “We are proud that Avtozma IV has now achieved full indication alignment with the reference Actemra IV. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS.
“This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.”
Celltrion said it expects to launch Avtozma IV in the US on 31 August, in accordance with its patent settlement agreement with Genentech. The company also holds a licence to market a subcutaneous formulation of the drug in the country, though the launch date for this remains confidential.
The authorisation comes less than two months after the FDA approved a new presentation of Celltrion’s SteQeyma, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat paediatric patients with plaque psoriasis or psoriatic arthritis.
It is hoped that the approval, which means that SteQeyma now offers all dosage forms and strengths of its reference product, will help meet physicians’ clinical needs and support treatment continuity for patients.