FDA Approves Biosimilar to ACTMRA

The U.S. Food and Drug Administration has approved Biogen’s tocilizumab-bavi (TOFIDENCE), a biosimilar option referencing ACTMRA, to treat moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (JIA). It is the first tocilizumab biosimilar approved in the U.S. The intravenous formulation is indicated for adult patients with moderately to severely active RA who had an inadequate response to ≥one disease-modifying antirheumatic drug, patients ≥2 years old with active PJIA and patients ≥2 years old with active systemic JIA.

The tocilizumab reference biosimilar was approved based on data from a randomized, double-blind, single-dose, parallel Phase I trial comparing the pharmacokinetics, safety and immunogenicity to both U.S. and European Union reference tocilizumab across three patient arms. Another randomized, double-blind, multiple-dose, three-arm Phase III trial that assessed the reference biologic to tocizilumab’s equivalent efficacy and comparable safety, pharmacokinetic and immunogenetic profiles in patients with RA inadequately controlled by methotrexate supported the reference biosimilar’s equivalence to tocizilumab.

“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, global head of biosimilars at Biogen. “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.”