On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab) recommended for reimbursement for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development. On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting, though has not yet proceeded to PBS-listing. However, Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.