On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.

New Biosimilar Listings

PBAC will consider the following applications for reimbursement of biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) for the first time: Accord Healthcare’s Denolia® and Deskleta® in 60mg/1mL pre-filled syringe (PFS), and Dexeva® and Dostiva® in 120mg/1.7mL PFS (each TGA-approved in October 2025).

Amgen’s Prolia® and Xgeva® are now sponsored in Australia by Arrotex, following a 2024 deal between the companies.  Denosumab biosimilars currently listed on the Pharmaceutical Benefits Scheme (PBS) are Sandoz’s Wyost® and Jubbonti® (PBS-listed 1 August 2025), Amgen’s supplemental denosumab brands Corora® and Ganvado® (PBS-listed 1 September 2025, sponsored by Arrotex) and Celltrion’s Stoboclo® and Osenvelt® (PBS-listed 1 March 2026).

The following biosimilars to Genentech’s Lucentis® (ranibizumab) will also be considered at the November PBAC meeting:

• Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026); and
• Generic Health’s Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).

The only other approved ranibizumab biosimilar in Australia is Samsung Bioepis’ Byooviz® (approved August 2022), which is not currently PBS-listed.

Amended Biosimilar Listings

Amgen has submitted a request for a “broad listing” of Amgevita® (for the higher concentration forms recommended by PBAC at its March 2026 meeting: 20mg/0.2ml & 40mg/0.4ml PFS and 80mg/0.8ml pre-filled pen (PFP)) for the treatment of immune-mediated inflammatory disease.

Originator Biopharmaceuticals

MSD is requesting PBS listing of a new subcutaneous form of Keytruda® (pembrolizumab) (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form.  The TGA approved both strengths of Keytruda SC™ (395mg/2.4mL and 790mg/4.8mL) on 23 July 2026.

Roche has resubmitted its request to list Susvimo® (ranibizumab), a solution for ocular implant (39.5mg/0.395mL), for the treatment of wet AMD.  This follows the PBAC’s decision against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system for the medicine.

Bayer has submitted a request to list high dose Eylea® (aflibercept, 8mg) in 114.3mg/mL intravitreal injection for the treatment of visual impairment due to macular oedema following branch or central retinal vein occlusion (RVO).  Eylea® 8mg has been PBS-listed for nAMD and diabetic macular oedema since 1 November 2024.

Dr Reddy’s Laboratories has submitted a request to list a new indication of Zytorvi® (toripalimab) in 240mg/6mL solution for IV infusion, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC).  Zytorvi® was first listed on the PBS on 1 December 2025 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP;
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
• Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.

Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively.  Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml).  There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025.  The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.

Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting.  However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting.  PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.

Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive marketing approval in Australia.

Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.

On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2026 edition reports that, as of March 2026, the FDA has approved 92 biosimilars across 20 unique biosimilar molecules, 67 of which have been launched in the US.  This is an additional 2 biosimilars approved and 3 launched since Q1/2026.  The biosimilars FDA approved in Q1/2026 were Accord Biopharma’s Filkri™ (filgrastim) (referencing Amgen’s Neupogen®) and Teva Pharmaceutical’s Ponlimsi™ (denosumab) (referencing Amgen’s Prolia®)  The Q1/2026 launches were Samsung Bioepis’ Ospomyv® (denosumab) (referencing Amgen’s Prolia®) and Gedeon Richter/Hikma’s Enoby® and Xtrenbo® (denosumab) (referencing Amgen’s Prolia® and Xgeva®, respectively).

Samsung Bioepis reports as “key highlights” increases in US market share of adalimumab biosimilars (to 60% as of February 2026), and ustekinumab biosimilars (an increase of 8% to 27% as of Q4/2025).  The increase in adalimumab biosimilar adoption is said to reflect the inclusion of Quallent private label sales in market share calculations beginning in 2026.

The Biosimilar Market Report summarises the FDA’s October 2025 and March 2026 draft guidance regarding streamlining biosimilar development, including by indicating that Clinical Efficacy Studies (CES) are no longer expected by default and clarifying that clinical data generated using a non-US-licensed comparator product may be used to support a US biosimilar application, provided sufficient scientific justification is established.  The Report concludes that reduced reliance on CES and increased flexibility in comparator sourcing “may lower development cost and complexity” and “may enable development across a broad set of reference products particularly in later-wave or smaller markets”.  However, the Report refers to market research suggesting that reduced reliance on CES is unlikely to materially impact coverage or formulary positioning, as FDA approval is viewed as the threshold for equivalence.

On 31 December 2025, Mabwell announced that it has received marketing approval from the Indonesian Food and Drug Authority for its Adalimumab Injection 9MW0113, biosimilar to AbbVie’s Humira®.

Mabwell jointly developed the biosimilar with Shanghai Junshi Biosciences and it was approved in China in March 2022, where it is marketed as Junmaikang®.  Mabwell reports that it has signed formal cooperation agreements for 9MW0113 in more than ten countries and has submitted registration applications in multiple countries, including Jordan and Peru.

Mabwell’s biosimilar portfolio also includes Mailishu® and Maiweijian™, referencing Amgen’s Prolia® and Xgeva® (denosumab), which were approved in China in March 2023 and April 2024, respectively, and first launched outside of China in December 2025.  According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several other key markets, including Jordan, Egypt, and Brazil.

On 23 December 2025, Biocon Biologics announced that is has secured full and exclusive global rights for Hulio®, biosimilar to AbbVie’s Humira® (adalimumab), from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB).

Under the new agreement, which supersedes an existing collaboration agreement between the companies which only granted Biocon commercialisation rights, Biocon will now be responsible for both manufacturing and commercialising the product and will also have rights for any additional development activities.  FKB will offset certain development costs incurred by Biocon and Biocon will pay a technology licence fee and royalties on sales to FKB for a specified period.

Commercial manufacturing of Hulio® at Biocon’s facilities will commence following completion of technology transfer and regulatory approvals.

Biocon originally acquired the commercialisation rights to biosimilar adalimumab through its acquisition of Viatris’ global biosimilars portfolio in November 2022, and completed the integration of the business in over 70 countries in July 2023, shortly followed by North America in September 2023.  Viatris had previously in-licensed the product from FKB.

Hulio® was first approved in Europe in 2018, the US in 2020 and Canada in February 2021.

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025.  In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025.  The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

On 30 October 2025, Celltrion announced that, according to IQVIA, its Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), has achieved 50% market share in Japan, surpassing competing innovator and biosimilars to become that top bevacizumab product.  Celltrion states that Vegzelma® has more than tripled its market share, which stood at 15% the same time last year.

Vegzelma®’s success follows that of Celltrion’s other oncology biosimilar, Herzuma®, referencing Roche’s Herceptin® (trastuzumab), which holds a 74% market share in Japan.  Celltrion further reports that its autoimmune disease portfolio has shown strong performance, with Remsima®, referencing Janssen’s Remicade® (infliximab), and Yuflyma®, referencing AbbVie’s Humira® (adalimumab), achieving market shares of 43% and 14%, respectively.

Celltrion attributes this growth to the success of its localised sales and distribution strategy, tailored to Japan’s Diagnosis Procedure Combination (DPC) system, a reimbursement framework that encourages the use of cost-effective medicines such as biosimilars.

In September 2025, Celltrion announced that its Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), became the first biosimilar tocilizumab approved in Japan.  This followed the Japanese launch of Celltrion’s biosimilar ustekinumab, Steqeyma®, referencing J&J/Janssen’s Stelara®, in July 2025.

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following presentations:

• 20mg/0.2mL (484565) and 40mg/0.4mL (484554) injection solution syringe; and
• 40mg/0.4mL (484553) and 80mg/0.8mL (486685) injection solution syringe with a pen injector.

There are a number of other high-concentration adalimumab biosimilars approved in Australia, including Celltrion’s Yuflyma® (March 2022), Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In March 2025, Sandoz’s high-concentration Hyrimoz® (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications, which followed PBS-listing of the 40 mg/0.4 mL injection, 2 x 0.4 mL pen presentation in January 2025.

On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up 3% on the previous quarter and now only one percentage point behind the leading product.

Celltrion stated that this is a “significant achievement” given that Yuflyma® joined the top prescription tier three years later than its competitors and in a “highly competitive market with over 10 adalimumab products”, including originator product Humira®.

In April 2025, Celltrion announced that it secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free presentation of Yuflyma®.  There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.

On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira® (adalimumab) in the Netherlands, finding that PAF did not hold the requisite interest in the claim.

PAF commenced proceedings against AbbVie in February 2023, alleging that AbbVie acted unlawfully by overcharging for Humira®, leading to the displacement of publicly insured health services and violating fundamental human rights under Article 2 of the European Convention on Human Rights, and further breached relevant competition laws by abusing its market power.

In a statement released on 9 July 2025, PAF says that it had estimated that AbbVie “earned as much as €1 billion in excess profit in the Netherlands, costing the health system an equivalent of 13,950 years of healthy life”, and that it was “disappointed that the court did not address the merits of [the] case”.  PAF is considering an appeal.