On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).
Sandoz’s natalizumab biosimilar, Tyruko® (300 mg in 15 mL vial for intravenous infusion) has been recommended for PBS-listing under the same circumstances as Biogen’s Tysabri®. Tyruko®, which was developed by Polpharma Biologics, is the first and only biosimilar natalizumab to have been approved in Australia (4 April 2025).
Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was recommended for PBS-listing (as 75 mg/0.5 mL and 150 mg/1 mL PFS) for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria. The PBAC considered that “the application of biosimilar uptake drivers to Omlyclo® would be clinically appropriate and would not impact cost effectiveness”. Such biosimilar uptake drivers include an Authority Required requirement for the inclusion of an administrative note across all Omlyclo® listings encouraging use of the biosimilar brand for treatment naïve patients. Omlyclo® is the first, and currently only, omalizumab biosimilar approved in Australia (November 2024).
Samsung Bioepis’ Epyztek® (ustekinumab) is recommended for PBS-listing for the same indications as its reference biologic, J&J’s Stelara®, in three forms: 45 mg/0.5 mL in a 0.5 mg PFS for injection, 90 mg/1 mL PFS for injection and solution for IV infusion 130 mg in 26 mL. As for Omlyclo®, PBAC considered that the application of biosimilar uptake drives to Epyztek® would be appropriate. Epyztek® was the fourth ustekinumab biosimilar to be approved in Australia in October 2024, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024). Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.