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  1. News & Events for Human Drugs

FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis


FDA approved Tofidence (tocilizumab-bavi) as biosimilar to U.S.-licensed Actemra (tocilizumab). This product is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. Tofidence is approved for the following indications currently approved for U.S.-licensed Actemra: Rheumatoid Arthritis in adults, Polyarticular Juvenile Idiopathic Arthritis ages 2 and older, and Systemic Juvenile Idiopathic Arthritis ages 2 and older. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis. Tofidence is administered via intravenous infusion.

Disease or Condition

Rheumatoid arthritis, or RA, is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body. RA mainly attacks the joints and can affect many joints at once.

Polyarticular Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis are also diseases that involve the inflammation of joints where two bones meet (arthritis). Joints may feel warm, swollen and tender. Polyarticular arthritis involves multiple joints, whereas systemic arthritis may also involve symptoms of fever, rash, lymph node enlargement, and spleen or liver enlargement.

Approval Information

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product. All biological products are approved only after they meet FDA’s rigorous approval standards.

FDA’s approval of Tofidence is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Actemra and that there are no clinically meaningful differences between the two products. This evidence included comparisons of the products on an analytical level using an extensive battery of physicochemical tests and biological assays.

Multiple lots manufactured for each product were compared across a broad range of different product quality attributes, and the results of these comparisons confirmed similarity in the structural and functional features of Tofidence and Actemra, including those known to impact safety and efficacy. The comparative clinical data to support approval of Tofidence included results from a pharmacokinetic study in healthy subjects that confirmed similar exposure following intravenous administration. In addition, a study in patients with rheumatoid arthritis who were inadequately controlled by methotrexate was conducted and demonstrated similarity in efficacy, safety and immunogenicity endpoints. The totality of these data supported FDA approval of Tofidence as biosimilar to Actemra.

Safety Information

The most common side effects associated with tocilizumab products are upper respiratory tract infections, nasopharyngitis (common cold), headache, hypertension, increased ALT (elevated liver enzymes), and injection site reactions.

See full prescribing information for additional information on risks associated with Tofidence.

More Information about Biosimilars

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