At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended a broad, multi-indication PBS listing of MSD’s Keytruda® (pembrolizumab) for the treatment of advanced or metastatic cancers.
The recommendation comes after MSD received a knock-back from PBAC for the multi-indication (broad) listing for Keytruda® in July 2025. At that time, in a decision MSD described as “bewildering”, PBAC had considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.” In reporting the outcomes of the December 2025 meeting, the PBAC noted that MSD has now “largely addressed its concerns from the July 2025 submission”.
The PBAC recommendation for Keytruda® follows a similar recommendation, made at PBAC’s September 2025 meeting, for a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.
The PBAC has recommended that pembrolizumab join the Risk Sharing Arrangement (RSA) that it had previously recommended for the nivolumab/ipilimumab broad listing (if that proceeds to listing), given that there are several indications where both pembrolizumab and nivolumab (± ipilimumab) would be treatment options in the same or similar population. The PBAC has asked the Department of Health to review each of the recommended broad listings after three years to ensure the use remained consistent with its intention.
In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam. A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®. In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.