Genentech’s ACTpen 162mg/0.9mL, a single-dose prefilled auto-injector of Actemra (tocilizumab) has been approved for the treatment of patients with moderate to severe rheumatoid arthritis (RA), and patients two years and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SIJA).
The US Food and Drug Administration’s approval comes after clinical data from two studies demonstrated positive reactions. The studies found that the single-dose subcutaneous (SC) administration of Actemra with the ACTpen was bioequivalent to Genentech’s intravenous formulation.
The clinical studies also showed that the intended users of the ACTpen, patients and caregivers, were successful in performing the administration via auto-injector.
“…We are pleased to offer an additional option to patients who may prefer using the new auto-injector over other formulations,” said Genentech’s chief medical officer, Sandra Horning, in a statement.
ACTPen is expected to be available in January 2019.
A competitive edge?
Bio-Thera is one such firm looking to compete in the Actemra market. In August of this year, the Chinese pharma company initiated a Phase I trial for BAT1806 – a potential biosimilar alternative to Actemra.