On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.   

For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments. 

Four biosimilars will be considered for new listings: 

• Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis 

• Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis 

• Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria 

• Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease 

One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). 

Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following: 

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.

On 30 July 2024, Roche announced that the European Commission has approved Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion (RVO).  This follows the positive CHMP opinion for the indication in June 2024.

This is the first approval for a bispecific antibody treatment for RVO, and the third indication approval for Vabysmo®, in the EU.

One day earlier, Vabysmo® was approved for RVO in Canada.  Vabysmo® has also been approved for RVO in the US (in October 2023) and Japan (in March 2024) .  It is approved in nearly 100 countries for nAMD and diabetic macular oedema.

On 29 July 2024, Roche Canada announced that Health Canada has approved Vabysmo® (faricimab) injection for macular edema secondary to retinal vein occlusion (RVO).   This is the third indication for Vabysmo® in Canada, following approvals for AMD and DME.

Vabysmo® has previously been approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.  It is approved in nearly 100 countries for nAMD and DME.

In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports that its Vabysmo® (faricimab) was well-tolerated in DME patients receiving treatment for up to 4 years.  The “RHONE-X” study met all primary endpoints, with more than 90% of patients free of DME after 4 years.

Vabysmo® was first approved in the US in January 2022 for nAMD and DME and is available in multiple countries, including Europe, Canada and Australia.  Vabysmo® was also approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.

On 5 July 2024, Roche announced that the FDA has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6 mg) for nAMD, diabetic macular oedema and macular oedema following retinal vein occlusion.  Roche reports that the product is the first PFS with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness. 

Vabysmo® was first approved in the US in January 2022 in a vial format and is available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion. 

Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion.  If approved, faricimab will be the first bispecific antibody treatment available in the EU for RVO.  A final decision of the European Commission is expected soon. 

Vabysmo has previously been approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.  It is approved in 95 countries for nAMD and diabetic macular oedema. 

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

• Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
• Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.

Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.  Vabysmo® was first  FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.