On 30 August 2026, Australia’s Minister for Health and Ageing, the Hon Mark Butler, announced that, from 1 September 2026, the listing of MSD’s Keytruda® (pembrolizumab) on the Pharmaceutical Benefits Scheme (PBS) will be expanded to a broad, multi-indication listing for the treatment of advanced or metastatic cancers. Keytruda® has already been PBS listed for 17 cancer indications and will now be reimbursed for additional cancers including advanced cholangiocarcinoma, ovarian cancer and Merkel cell carcinoma.
Keytruda® was recommended by the Australian Pharmaceutical Benefits Advisory Committee (PBAC) for the broad, multi-indication PBS listing at its December 2025 intracycle meeting. The recommendation came 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 had “largely addressed its concerns from the July 2025 submission”.
According to the Health Minister’s announcement, the broad PBS listing for Keytruda® is likely to benefit about 700 Australians, who, without the PBS subsidy may have been paying approximately AU$14,800 per script.
BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) also have a multi-indication PBS listing for advanced or metastatic cancers, which took effect in March 2026 following a recommendation made at the PBAC’s September 2025 meeting.
Separately, Keytruda® will also be newly PBS listed from 1 September 2026 in combination with Astellas’ Padcev® (enfortumab vedotin) for the treatment of patients with Stage 3 or 4 urothelial cancer.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).
There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up. Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively). In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.
Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.