On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s natalizumab biosimilar, Tyruko® (300 mg in 15 mL vial for intravenous infusion) has been recommended for PBS-listing under the same circumstances as Biogen’s Tysabri®.  Tyruko®, which was developed by Polpharma Biologics, is the first and only biosimilar natalizumab to have been approved in Australia (4 April 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was recommended for PBS-listing (as 75 mg/0.5 mL and 150 mg/1 mL PFS) for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria.  The PBAC considered that “the application of biosimilar uptake drivers to Omlyclo® would be clinically appropriate and would not impact cost effectiveness”.  Such biosimilar uptake drivers include an Authority Required requirement for the inclusion of an administrative note across all Omlyclo® listings encouraging use of the biosimilar brand for treatment naïve patients.  Omlyclo® is the first, and currently only, omalizumab biosimilar approved in Australia (November 2024).

Samsung Bioepis’ Epyztek® (ustekinumab) is recommended for PBS-listing for the same indications as its reference biologic, J&J’s Stelara®, in three forms: 45 mg/0.5 mL in a 0.5 mg PFS for injection, 90 mg/1 mL PFS for injection and solution for IV infusion 130 mg in 26 mL.  As for Omlyclo®, PBAC considered that the application of biosimilar uptake drives to Epyztek® would be appropriate.  Epyztek® was the fourth ustekinumab biosimilar to be approved in Australia in October 2024, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024).  Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.

On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product.

Omlyclo® is the first omalizumab biosimilar approved in New Zealand.  It was also the first omalizumab biosimilar to be approved in the US (March 2025), Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

Alvotech/Kashiv Biosciences, Aurobindo, Teva and Glenmark are reported to have omalizumab biosimilars under development.

In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK omalizumab formulation patent (EP 3805248), finding it was valid and infringed by Celltrion.

Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  The injector formulation will be supplied in 75mg and 150mg doses.

Celltrion’s omalizumab biosimilar was approved (in pre-filled syringe) in the US in March 2025, Canada in December 2024, Australia in November 2024, the UK in July 2024, Korea in June 2024 and Europe in May 2024.

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, under which Alvotech was responsible for development and manufacture, while Advanz Pharma handles registration and commercialisation.  In October 2023, Alvotech entered into an exclusive licensing agreement with Kashiv in relation to AVT23.  Under that agreement, Alvotech has an exclusive licence to commercialise AVT23 in the EU, the UK, Australia, Canada, and New Zealand, while Kashiv is responsible for the development and manufacturing of the biosimilar.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was the first to be approved in the UK in July 2024.  In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK patent for an omalizumab formulation (EP (UK) 3 805 248), finding it was valid and infringed by Celltrion.

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcutaneous use.  The approval covers all US indications of Xolair®, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.

Omlyclo® was the first omalizumab biosimilar to be approved in Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

On 30 January 2025, the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) was valid and infringed by Celltrion.  The UK Court judgment followed a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague), and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark have previously been reported to have omalizumab biosimilars under development.

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.

The decision was delivered in a proceeding commenced by Celltrion at the end of July 2023, seeking to revoke the patent on grounds including lack of novelty, lack of inventive step and insufficiency.  In September 2023, Genentech/Novartis filed a counterclaim for infringement.  Celltrion admitted that it infringed the patent if it was held to be valid.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was approved in the UK in July 2024.  It has also received approval in Europe (May 2024),  South Korea (June 2024), Australia (November 2024) and Canada (December 2024).  Celltrion submitted an aBLA in the US for Omlyclo® in March 2024.

The UK Court judgment follows a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.  This was based on a lack of any “concrete indications” of any “imminent infringement” of the patent by Celltrion.  Although Celltrion had obtained European marketing authorisation for Omlyclo®, the Court found there was insufficient evidence of any specific timeline for price negotiations or that reimbursement applications had been made.  There was also no evidence of any samples actually being provided to potential customers.  In these circumstances, Novartis/Genentech’s application for provisional measures was refused.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are also ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague) and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  

The May 2025 agenda lists 8 biologics for consideration, 3 of which are listed for new PBS additions:  

New listing applications

• UCB’s Bimzelx® (bimekizumab) moderate to severe hidradenitis suppurativa
• AstraZeneca’s Imjudo® (durvalumab) in combination with tremelimumab for the first line treatment of patients with advanced (unresectable) Stage B Barcelona clinic liver cancer or Stage C hepatocellular carcinoma.
• Accelagen’s Briumvi® (ublituximab) for relapsing-remitting multiple sclerosis

Amendment applications

• GSK’s Jemperli® (dostarlimab) for use in combination with platinum-containing chemotherapy for the treatment of primary advanced or first recurrent mismatch repair proficient endometrial cancer
• Janssen’s Tremfya® (guselkumab) for severe chronic plaque psoriasis
• Novartis’ Xolair® (omalizumab) for CRSwNP
• Novartis’ Lucentis® (ranibizumab) for proliferative diabetic retinopathy
• AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for gastric or gastroesophageal junction cancer

In November 2024, PBAC previously published its agenda for the March 2025 meeting, which will consider 23 monoclonal antibodies, including four biosimilars. 

On 9 December 2024, Celltrion announced that Omlyclo® (CT-P39), biosimilar to Genentech/Novartis’ Xolair® (omalizumab) was approved by Health Canada.  The approval is for all indications of Xolair®, including allergic asthma, idiopathic urticaria and chronic rhinosinusitis with nasal polyps and follows the submission of Celltrion’s application in December 2023.

Omlyclo® is the first omalizumab biosimilar to be approved in Canada.  It was also the first to be approved in Europe (May 2024), South Korea (June 2024), the UK (July 2024) and Australia (November 2024).  Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024.

Novartis/Genentech and Celltrion are involved in UPC proceedings regarding alleged infringement of EP3805248 relating to an omalizumab formulation.  In September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion.

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 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia.  Omlyclo® is the first omalizumab biosimilar approved in Australia. 

Omylclo® was approved in Australia for two presentations:

• 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard (427223) 

• 150 mg/ mL solution for injection in a pre-filled syringe with needle guard (427224) 

Whilst there are no Australian patent proceedings on foot to date regarding omalizumab, Novartis/Genentech and Celltrion are involved in UPC proceedings regarding alleged infringement of EP3805248 relating to an omalizumab formulation.  In September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion. 

Celltrion’s Omlyclo® is approved in  Europe (May 2024), the  UK (July 2024) and  South Korea (June 2024).  Celltrion  submitted an aBLA in the US  for its omalizumab biosimilar in March 2024 and in  Canada in December 2023.  

KashivBiosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.