New biosimilars, B-cell therapies, and vaccines could reshape patient access.
The March 2026 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) is shaping up as a significant one for rheumatology, with multiple submissions that span biosimilar uptake, autoinflammatory disease management, severe autoimmune complications and adult vaccination programs.
Among the key items is Sandoz’s application for a new ustekinumab biosimilar, Ardelya, which seeks PBS General Schedule listing for 45mg and 90mg pre-filled syringes for use in severe psoriatic arthritis and severe chronic plaque psoriasis.
Designed to mirror the originator’s indications and delivery options, the bid will prompt the PBAC to review biosimilarity, interchangeability and projected system-wide savings.
For rheumatologists, the potential addition of Ardelya reflects continued policy momentum toward expanding biosimilar availability in IL-12/23 inhibition, where competition may help broaden access and reduce treatment cost pressures.
Novartis is requesting for a new Section 100 listing for canakinumab (Ilaris), aimed at ensuring continuity of subsidised treatment for young adults with colchicine-resistant or colchicine-intolerant Familial Mediterranean Fever (crFMF).
The application is designed to address a long-recognised transition gap, as current PBS arrangements fund treatment initiated in childhood but do not guarantee continuation beyond age 18 years.
Canakinumab has become a mainstay therapy for severe paediatric FMF, and the proposed listing (Authority Required via telephone or online) proposes to prevent disruption for this small but vulnerable cohort.
AFT Pharmaceuticals is also seeking to expand PBS treatment options with Vevye, a ciclosporin 1mg/mL eye drop formulation intended for adults with dry eye disease associated with keratitis who have not responded adequately to artificial tears alone.
If recommended under the General Schedule with Authority Required access, the product would add an additional immunomodulatory option for persistent ocular surface inflammation, complementing international use of ciclosporin in chronic dry eye management.
Roche is returning to the PBAC to pursue a broadened Section 100 listing for obinutuzumab (Gazya) for adults with active class III or IV lupus nephritis, with or without class V involvement, who are receiving standard treatment with mycophenolate and corticosteroids.
The submission reflects the growing interest in B-cell–directed therapies for refractory lupus nephritis, an area of substantial unmet need where many patients experience ongoing disease activity despite optimised background therapy.
If supported, obinutuzumab would become a subsidised adjunctive option for one of the most serious complications of systemic lupus erythematosus and would be accessible under Authority Required arrangements.
Biosimilar competition is also set to intensify in the TNF inhibitor category, with new adalimumab presentations from both Amgen and Celltrion Healthcare scheduled for consideration.
Amgen has submitted four higher-concentration, citrate-free formulations of Amgevita, including 20mg/0.2 mL and 40mg/0.4 mL pre-filled syringes and 40mg/0.4 mL and 80mg/0.8 mL pre-filled pens, seeking listings across both the General Schedule and Section 100 programs for all indications currently covered by adalimumab.
These include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn’s disease and ulcerative colitis, among others.
Celltrion’s application for its 20mg/0.2 mL Yuflyma syringe aims to match the originator’s low-dose paediatric presentation, covering a broad set of inflammatory and autoimmune indications under Authority Required pathways.
If endorsed, the listings would further diversify the adalimumab device landscape and support ongoing transition to higher-concentration, lower-volume formulations.
Related
In the immunisation domain, GlaxoSmithKline’s RSV vaccine Arexvy will be reconsidered for an expanded National Immunisation Program (NIP) listing.
The resubmission seeks funded access for high-risk adults aged 60 to 74 years, drawing on new clinical and epidemiological data suggesting benefit in populations younger than the currently funded 75 years and over and Aboriginal and Torres Strait Islander adults aged 60 to 74 years.
The PBAC will revisit cost-effectiveness assumptions in light of updated modelling, international post-licensure data and evolving estimates of RSV disease burden. A positive outcome would align Australia more closely with international moves toward earlier RSV vaccination in vulnerable older adults.
Moderna’s Spikevax covid vaccine is also on the agenda for a proposed new NIP listing for adults aged 18 years and over with specific medical conditions that increase their risk of severe covid. The submission reflects the pandemic’s transition into an endemic phase, with sustained disproportionate risk among individuals with chronic or immunocompromising conditions.
If recommended, the listing would formalise funded access for a defined cohort and help shape the future structure of Australia’s covid vaccination program.
Consumer consultation for the March meeting is open until 21 January 2026. The PBAC will publish outcomes from the March 2026 meeting later in the year.
Outcomes from the PBAC’s November meeting will be published on 19 December. For more information, see here.
