Mycenax’s Actemra biosimilar edges closer to approval

Mycenax’s biosimilar of Roche’s Actemra (tocilizumab), LusiNEX, has been shown to match its originator’s profile in a phase I PK trial, meaning it is on track to become the first approved biosimilar for the drug. Actemra, marketed as RoActemra in the EU, is approved for immunology and musculoskeletal disorders including rheumatoid arthritis.
The double-blinded, randomized, 3-arm parallel study was conducted in Australia and New Zealand. Three randomized groups of 190 healthy subjects received a single intravenous dose (4 mg/kg) of either LusiNEX or originator products (EU-RoActemra or US-Actemra). After dosing, study participants underwent an 8-week assessment period to evaluate its bioequivalence in terms of pharmacokinetic (PK), safety and tolerability. The study’s primary endpoint was the area under the concentration-versus-time curve calculated from the start of the infusion until infinity (AUC 0-inf). The study’s prespecified bioequivalence margin was 80% to 125%.