Approvals

The FDA’s approval of the drug followed comprehensive analytical, non-clinical and clinical data submitted to the FDA in September 2022. Also, a randomised, double-blind, single-dose, three-arm, parallel phase 1 study compared the pharmacokinetics, safety and tolerability of the drug with the US and EU reference tocilizumab in healthy volunteers. Then a randomised, double-blind, multi-dose, three-arm, parallel phase 3 study compared the drug with its reference to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles in patients with rheumatoid arthritis inadequately controlled by methotrexate.

Ian Henshaw, global head of Biosimilars at Biogen, commented: “The approval of TOFIDENCE in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies. With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

The drug is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idopahic arthritis and systemic juvenile idiopathic arthritis. Tofidence is the first biosimilar of this drug to be approved in the US.