FDA Approves Tofidence, the First Biosimilar to Tocilizumab

The Food and Drug Administration (FDA) has approved Tofidence™ (tocilizumab-bavi), the first biosimilar to tocilizumab (Actemra^®).

Tofidence, an interleukin-6 receptor antagonist, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs; for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; and for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

The FDA approval was based on data demonstrating that Tofidence is highly similar to the reference product, with no clinically meaningful differences.  To support the approval, Biogen conducted a phase 1 study evaluating the pharmacokinetics, safety, and immunogenicity of Tofidence vs tocilizumab in healthy participants (ClinicalTrials.gov Identifier: NCT03606876), as well as a phase 3 study comparing the biosimilar to the reference product in patients with RA inadequately controlled by methotrexate (ClinicalTrials.gov Identifier: NCT03830203).

Findings from the phase 3 study showed similar efficacy between the Tofidence and tocilizumab groups. At week 12, 69% of patients in the biosimilar arm achieved an American College of Rheumatology 20 (ACR20) percent response (primary endpoint) compared with 65% of patients in the tocilizumab arm. At week 24, ACR20 response was achieved in 69% of the biosimilar arm and 68% of the tocilizumab arm. Comparable pharmacokinetic, safety and immunogenicity profiles were also reported.

“The approval of Tofidence in the US 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 health care systems and an increase in physician choice and patient access to biologics.”

Tofidence is supplied as a preservative-free solution in 20mg/mL single-dose vials (80mg/4mL, 200mg/10mL, 400mg/20mL). It is administered as an intravenous infusion following further dilution.