FDA Approves Tofidence: A Biosimilar for Autoimmune Diseases

FDA Approves Tofidence: A Biosimilar for Autoimmune Diseases

Tofidence for Autoimmune Diseases

FDA approved Tofidence (tocilizumab-bavi) as biosimilar to U.S.-licensed Actemra (tocilizumab) [1]. 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.

The Impact of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

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 also cause 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.

Safety and Efficacy

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.

Looking Ahead: The Launch of Tofidence in the U.S.

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.

With the FDA's approval, Biogen is assessing the optimal launch timeline for Tofidence in the U.S. The healthcare community is watching with optimism as Tofidence promises to make a significant impact on the treatment options available for autoimmune diseases, reflecting the culmination of extensive scientific validation and the potential for improved patient outcomes.


[1]: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis