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Hisun Phase I tocilizumab study demonstrates bioequivalence with Genentech’s Actemra®

Jul 4, 2023

A Hisun phase I study has demonstrated pharmacokinetic similarity and bioequivalence between HS628, a proposed tocilizumab biosimilar to Genentech’s Actemra®.  The safety and immunogenicity profiles of HS628 were also found to be similar to the reference product in healthy Chinese male subjects.  Actemra® is approved in the US for the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis patients.  The study also notes that a phase III clinical trial is currently underway to compare the efficacy and safety of HS628 and Actemra® in patients with moderate to severe RA.

On 5 June 2023, Dr Reddy’s announced a successful phase I study of its biosimilar to Actemra®.