FDA approves first biosimilar to Actemra to treat adult and paediatric arthritis
Tofidence (tocilizumab-bavi) is FDA-approved as a biosimilar to Actemra. This medication suppresses the immune system by targeting specific inflammatory proteins as an IL-6 receptor antagonist. Tofidence is approved for the same indications as U.S.-licensed Actemra: adult rheumatoid arthritis, polyarticular and systemic juvenile idiopathic arthritis.
Rheumatoid arthritis as a disease
RA is an autoimmune and inflammatory disease in which your immune system mistakenly assaults healthy cells, causing inflammation (painful swelling) in the affected areas. RA mostly targets joints and can affect multiple joints.
Both polyarticular and systemic juvenile idiopathic arthritis cause inflammation of joints where two bones touch. Swollen, painful joints may be heated. Polyarticular arthritis affects numerous joints, while systemic arthritis can cause fever, rash, lymph node enlargement, and spleen or liver enlargement.
Approval Information
A biosimilar is a biological product that is substantially comparable to an FDA-approved reference product and has no clinically relevant deviations. This means biosimilars are as safe and effective as reference products. All biological products must pass the FDA’s strict clearance process.
After a thorough scientific review, it was revealed that Tofidence is comparable to Actemra and has no clinically significant differences. This evidence comprised thorough physicochemical and biological experiments to compare the products for analysis.
Multiple lots of each product were examined over a wide range of product quality qualities, and the results showed that Tofidence and Actemra have identical structural and functional features, including safety and efficacy aspects. A trial in methotrexate-uncontrolled rheumatoid arthritis patients showed identical effectiveness, safety, and immunogenicity outcomes. Overall, these findings supported FDA approval of Tofidence as an Actemra biosimilar.
Safety information
Upper respiratory tract infections, nasopharyngitis (common cold), headache, hypertension, raised ALT, and injection site responses are the most prevalent tocilizumab side effects.
See full prescribing information for additional information on risks associated with #Tofidence.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis#:~:text=FDA%20approved%20Tofidence%20
https://investors.biogen.com/news-releases/news-release-details/fda-approves-biogens-tofidencetm-tocilizumab-bavi-biosimilar