On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).
Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu™, have been recommended for PBS-listing under the same circumstances as reference biologic, Regeneron/Bayer’s Eylea®. Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).
Biocon Biologic’s Nepexto® (pre-filled syringe), biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was also recommended for PBS-listing (sponsor: Maxx Pharma). Nepexto® (50mg/1ml auto-injector) became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017. In July 2025, Biocon Biologics announced that it launched Nepexto® in Australia.
Celltrion’s Remsima® (IV formulation), biosimilar to Janssen’s Remicade® (infliximab), has also been recommended by PBAC. Remsima® IV was approved by the TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).
Among the originator biopharmaceuticals, Roche/Genentech’s Ocrevus® (ocrelizumab) SC formulation was recommended for PBS listing under the same circumstances as the IV formulation, following its approval in Australia in March 2025.
There are a number of ocrelizumab biosimilars currently in development. On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, which includes modifying its Phase 1/3 trial for biosimilar ocrelizumab, CYB704, so that it will become a comparative pharmacokinetic trial. In January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials. Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).