On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:

• Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to Janssen’s Stelara®, for first time PBS listing (5 mg/0.5 mL injection, 45 mg/0.5 mL and 90 mg/1 mL pre-filled syringe (PFS) and 130 mg/26 mL solution for IV infusion). Yesintek® was approved by the TGA in each of these presentations in April 2026.
• Celltrion’s Steqeyma® (ustekinumab) for 3 new formulations (45 mg/0.5 mL vial, and 45 mg/0.5 mL and 90 mg/1 mL pre-filled pen (PFP)). Steqeyma® was the first ustekinumab biosimilar to be PBS listed on 1 August 2025 (45 mg/0.5 mL and 90 mg/1 mL PFS and 130 mg/26 mL solution for IV infusion).
• Celltrion’s Eydenzelt® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2 mg, for four additional indications: subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD), diabetic macular oedema (DMO), branch retinal vein occlusion (BRVO) with macular oedema (MO) and central retinal vein occlusion (CRVO) with MO. Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV).  Although recommended for PBS listing in November 2025 for the same indication, it has not yet completed the government processes required for PBS listing.

In addition to Steqeyma®, the only other ustekinumab biosimilar currently listed on the PBS is Amgen’s Wezlana®.  Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time.  Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.

Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting.  Samsung Bioepis lodged documentation required for PBS listing on 10 July 2026, with the next step in the process (agreement on listing arrangements) having commenced on 14 July 2026.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

The only Eylea® (aflibercept) biosimilar that is PBS listed in Australia is Sandoz’s Afqlir®, which was listed in February 2026 in vial and pre-filled syringe presentations for all reference indications.

On 18 August 2026, Korea Biomedical Review reported that Sam Chun Dang (SCD) signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg.  The financial terms of the settlement have not been disclosed.

Under the agreement, the parties will terminate all pending patent proceedings regarding aflibercept in the relevant jurisdictions, including:

• an infringement lawsuit filed by Regeneron against SCD in the Munich Regional Court on 1 April 2026;
• opposition proceedings in the European Patent Office and the Korean Intellectual Property Office concerning Regeneron’s aflibercept patents;
• Korean litigation filed in January 2024 by Regeneron and Bayer in the Seoul Central District Court against SCD and its subsidiary, Optus Pharmaceutical, alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 infringed Regeneron’s Korean Patent No. 659477. Regeneron/Bayer were seeking damages and restrictions related to the manufacture and sale of SCD411; and
• Japanese patent proceedings, about which there is little information publicly available.

It does not appear that the settlement addresses the pending Taiwanese patent infringement litigation commenced in February 2026 by Regeneron against the Taiwanese manufacturer of SCD411 (Mycenax Biotech Biopharmaceutical).

SCD411 was approved in vial and pre-filled syringe forms in Japan and Korea in September 2025.  It was launched in Korea as Vgenfli™ in December 2025, despite the pending patent infringement litigation commenced by Regeneron and Bayer, as no injunction was in place preventing sales.  SCD11 has not yet been launched in Japan, where the product is to be commercialised by Senju Pharmaceutical.

In Europe, SCD11 was approved as Vgenfli™ in August 2025, with Zaklady Farmaceutyczne Polpharma as the marketing authorisation holder.  SCD has announced licence agreements with an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

SCD and its US exclusive licensee, Fresenius Kabi, settled US aflibercept litigation with Regeneron/Bayer in February 2026.  The settlement permits Fresenius to launch SCD411/Vygenfree™ in the US at an undisclosed time.  The FDA accepted SCD’s application for SCD411 for review in December 2025 but the biosimilar has not yet been FDA-approved.

Regeneron, Bayer and Apotex, Sam Chun Dang’s commercialisation partner under an August 2023 agreement, settled their Canadian aflibercept litigation in June 2024.  Health Canada approved SCD11 as Aflivu™ in June 2025 and it was launched in July 2025.

On 13 August 2026, Bayer announced that China’s National Medical Products Administration (NMPA) has accepted for review its application for Eylea® (aflibercept) 8 mg (114.3 mg/ml solution) for injection) for the treatment of macular oedma following retinal vein occlusion (RVO).

Eylea® 8 mg is already approved in China for nAMD.  It has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023).  It is also approved for the treatment of patients with macular oedema following RVO including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).

Eylea® 8 mg, known in the US as Eylea HD®, was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Alvotech is developing a high dose aflibercept biosimilar, AVT29.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2 mg) in the US.  Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.

Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated completion date of January 2028.

On 11 August 2026, Mabwell announced that it has entered into licensing and commercialisation agreements with unidentified partners in the Philippines, Vietnam and Malaysia for 9MW0813, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg.

Under the terms of the agreements, Mabwell and its partners will work collaboratively to advance the product’s registration and commercialisation in each country.  The announcement did not disclose the partners, financial terms or expected timeline for launch.

Mabwell’s biosimilar aflibercept was approved by China’s National Medical Products Administration (NMPA) in September 2025 for the treatment of diabetic macular oedema and neovascular (wet) age-related macular degeneration.

Mabwell has previously entered into licensing and commercialisation agreements for its denosumab biosimilars (Maiweijian™/9MW0321 and Mailishu™/9MW0311, biosimilars to Amgen’s Xgeva® and Prolia®) in the Philippines (July 2025 with UNILAB), Vietnam (March 2026 with undisclosed company) and Malaysia (April 2026 with undisclosed company).  Under these agreements, Mabwell is responsible for the development, production and commercial supply of the products whilst the partner is responsible for registration, marketing and commercialisation.

On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL).  Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe in a vial form in May 2026.

The original launch of Opuviz® followed a settlement agreement between Samsung Bioepis and Regeneron/Bayer announced in January 2026 under which Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of SB15 in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU (in November 2024) and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

Other aflibercept biosimilars launched in UK/Europe, including in PFS form, include Sandoz’s Afqlir® (UK launch in November 2025), Celltrion’s Eydenzelt® (UK/EU launch in December 2025), Biocon’s Yesafili® (UK launch in January 2026), Alvotech’s Mynzepli® (UK launch January 2026) and Formycon/Klinge’s Ahzantive®/Baiama® (EU launch in May 2026).

On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.

Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026.

Yesafili™ is only the second aflibercept biosimilar on the US market, following the launch of Amgen’s Pavblu® in October 2024, after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to that biosimilar. The FDA has not designated Pavblu® as interchangeable with Eylea®.

Biocon’s launch of Yesafili™ leads a stream of upcoming aflibercept biosimilar launches in the US resulting from litigation settlements, including Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 due to launch Q4/2026, subject to regulatory approval).

In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili™ in Europe and ROW, permitting Biocon to commercialise Yesafili™ in Europe/ROW from March 2026, other than in the UK (where it launched in January 2026) and Canada (where it launched in July 2025 as a result of a Canadian settlement).

On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”.  The routine cGMP surveillance inspection was conducted in May 2026.

The VAI classification means objectionable conditions or practices were found during the inspection, however the FDA did not take or recommend any administrative or regulatory action.   Alvotech’s CEO, Lisa Graver, stated that “the actions we have taken have effectively addressed the observations identified”.

Alvotech resubmitted its BLAs for AVT05 (golimumab) and AVT06 (aflibercept) to the FDA in June 2026.  This followed the receipt of Complete Response Letters from the FDA for Alvotech’s golimumab, aflibercept, and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively, and a subsequent  “remediation project” undertaken by Alvotech to address the FDA’s comments.

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.

On 8 July 2026, Teva and Samsung Bioepis announced that they have entered an agreement for the commercialisation in Canada of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®.  Under the terms of the licence and commercialisation agreement, Samsung Bioepis is responsible for the manufacture and registration of Opuviz®, while Teva has the Canadian commercialisation rights.

Samsung Bioepis had previously partnered with Biogen in relation to Opuviz® in Canada (and certain other countries) under a November 2019 agreement.  However, in October 2024, Biogen notified Samsung Bioepis of its decision to terminate that agreement for the US and Canada and the commercialisation rights reverted to Samsung Bioepis.

SB15 was approved in Canada in October 2025 but has not yet been launched on the Canadian market.  Samsung Bioepis entered settlement agreements with Regeneron/Bayer in relation to SB15 for the US & Canada (announced February 2026) and for Europe and ROW (announced January 2026), which provided agreed launch dates for SB15 in the jurisdictions covered by the agreements. However, the agreed launch date for Canada has not been made public.

Other aflibercept biosimilars approved in Canada include Biocon’s Yesafili® (June 2025, launched July 2025 following a settlement with Regeneron/Bayer), Amgen’s Pavblu® (July 2025), Apotex’s Aflivu™ (July 2025), Sandoz’s Enzeevu® (October 2025, launched February 2026), Celltrion’s Eydenzelt® (November 2025), and Formycon/Klinge/Valorum Biologics’ Ahzantive™ (November 2025).

Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe through direct sales in May 2026.  SB15 was approved in Korea (as Afilivu®) in February 2024 and in Australia (as Opuviz®) in September 2025.  Opuviz® was approved in the US in May 2024 and is set for a US launch from January 2027 under Samsung Bioepis’ settlement agreement with Regeneron/Bayer.

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.