On 8 October 2026, Lupin obtained approval in Australia for three generic ranibizumab products (biosimilars to Novartis’ Lucentis®) under three different brand names, Simulara®, Solentis® and Zivra™. Each brand is approved in two different formats: 2.3mg/0.23mL solution for injection vial and 1.65mg/0.165 mL solution for injection pre-filled syringe.
Lupin’s wholly owned Australian subsidiary, Generic Health, recently applied for PBS listing of the three brands, with the applications to be considered at the November 2026 PBAC meeting. Interestingly, Sandoz is the registered owner of the Simulara® trade mark (suggesting that Sandoz may launch one of these biosimilars) and originator Novartis is the registered owner of the Solentis® trade mark in Australia and in some overseas countries (suggesting that perhaps Novartis will seek to cannibalise its own ranibizumab market with the launch of a biosimilar in Australia). There is no Australian registered trade mark application for Zivra™.
Prior to Lupin’s approvals, there were two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved February 2026), and Samsung Bioepis’ Byooviz® 10 mg/mL solution for injection vial (approved August 2022). No biosimilar product has been launched to date in Australia. Actor has applied for PBS listing of its biosimilar ranibizumab, with that PBS application also to be considered at the November 2026 PBAC meeting at the same time as Lupin’s. Despite its approval in 2022, Samsung Bioepis’ Byooviz® is not yet PBS-listed, and there is no suggestion that any PBS application has been made to date.