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. 

On 6 September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of EP3805248 relating to an omalizumab formulation.

The UPC proceedings (case Numbers: ACT_18492/2024 and ACT_18551/2024) were commenced on 9 April 2024, and heard on 31 July 2024.  They relate to Celltrion’s Omlyclo® (CT-P39), biosimilar to Novartis/Genentech’s Xolair® (omalizumab).

In this week’s decision, four judges held that there were no “concrete indications” of any “imminent infringement” of the patent by Celltrion.  According to the UPC, in order for an infringement to be imminent in this case, all pre-launch preparations must have been completed in such a way that an offer for supply could be made at any time.  Although Celltrion had obtained European marketing authorisation for Omlyclo® in May 2024, 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.

As set out in the UPC decision, disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the UK, 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 EP3805248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

Celltrion’s Omlyclo® has been 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.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

As previously reported, on 9 April 2024, Novartis and Genentech commenced proceedings in the Dusseldorf Local Division of the UPC (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion in relation to EP 2805248 regarding pharmaceutical formulations of omalizumab, marketed by Novartis and Genentech as Xolair®.

Juve Patent reports that the dispute was heard before four UPC Judges on 31 July 2024, with a judgment to be handed down on 6 September 2024.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39) was the first omalizumab biosimilar to be approved in the UK in early July 2024 and in Europe in May 2024.

On 25 July 2024, Kashiv BioSciences announced completion of patient enrolment in a Phase III trial of ADL018, its biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).  The study aims to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic following H1 antagonist treatment.  

Kashiv completed a Ph I clinical trial for ADL018 on 30 June 2023.  On 1 July 2024, Kashiv and Amneal Pharmaceuticals announced they had entered into an exclusive licence agreement for the US in relation to ADL018.  In October 2023, Alvotech announced that it had entered an exclusive licensing agreement with Kashiv for ADL018 (AVT23) in the EU, UK, Australia, Canada, and New Zealand. 

On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic idiopathic urticaria. Omlyclo® is the first omalizumab biosimilar approved in the UK.

Omlyclo® was also the first omalizumab biosimilar approved in Europe, in May 2024, and in South Korea, in June 2024.  Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.

Celltrion is currently defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.

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

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).   
 
ADL018 was developed by Kashiv and is currently in a Phase III clinical trial, commenced in October 2023, in patients with chronic idiopathic/spontaneous urticaria.  Kashiv completed a Phase I clinical trial for ADL018 on 30 June 2023. 
 
Amneal and Kashiv have previously partnered including in relation to Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022. 
 
In October 2023, Alvotech announced that it had entered an exclusive licensing agreement with Kashiv for ADL018 (AVT23) in the EU, UK, Australia, Canada, and New Zealand.