September 2026 has been a busy month for ranibizumab with two new registrations on the Australian Register of Therapeutic Goods (ARTG): Novartis’ Vurjor® (1.65mg/0.165mL solution prefilled syringe (18 September)) and Roche’s Susvimo® (100mg/mL solution for injection vial for use with the Contivue® ocular implant (24 September)).
Vurjor® is a new brand for Novartis, with all of Novartis’s previous ranibizumab ARTG registrations under its Lucentis® brand. Novartis is yet to seek listing of Vurjor® on the Pharmaceutical Benefits Scheme (PBS). Vurjor® is approved for the same indications as Lucentis® for the treatment of adults.
Roche’s Susvimo® is delivered via an ocular implant, marketed as Contivue®, for continuous release into the vitreous of the eye. It is indicated for the treatment of adult patients with nAMD who have previously responded to at least two intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors.
Roche has applied to list Susvimo® on the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) had previously decided against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system. Roche has resubmitted its request for PBS-listing of Susvimo®, which will be considered by PBAC at its November 2026 meeting.
There are currently two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026), and Samsung Bioepis’ Byooviz® (approved August 2022). Actor has applied for PBS listing of its biosimilar ranibizumab, as has Generic Health in relation to Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved). Those PBS applications will be considered at the November PBAC meeting.