On 30 August 2026, Australia’s Minister for Health and Ageing, the Hon Mark Butler, announced that, from 1 September 2026, the listing of MSD’s Keytruda® (pembrolizumab) on the Pharmaceutical Benefits Scheme (PBS) will be expanded to a broad, multi-indication listing for the treatment of advanced or metastatic cancers.  Keytruda® has already been PBS listed for 17 cancer indications and will now be reimbursed for additional cancers including advanced cholangiocarcinoma, ovarian cancer and Merkel cell carcinoma.

Keytruda® was recommended by the Australian Pharmaceutical Benefits Advisory Committee (PBAC) for the broad, multi-indication PBS listing at its December 2025 intracycle meeting.  The recommendation came after MSD received a knock-back from PBAC for the multi-indication (broad) listing for Keytruda® in July 2025.  At that time, in a decision MSD described as “bewildering”, PBAC had considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”  In reporting the outcomes of the December 2025 meeting, the PBAC noted that MSD had “largely addressed its concerns from the July 2025 submission”.

According to the Health Minister’s announcement, the broad PBS listing for Keytruda® is likely to benefit about 700 Australians, who, without the PBS subsidy may have been paying approximately AU$14,800 per script.

BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) also have a multi-indication PBS listing for advanced or metastatic cancers, which took effect in March 2026 following a recommendation made at the PBAC’s September 2025 meeting.

Separately, Keytruda® will also be newly PBS listed from 1 September 2026 in combination with Astellas’ Padcev® (enfortumab vedotin) for the treatment of patients with Stage 3 or 4 urothelial cancer.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up.  Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

On 28 August 2026, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB35, biosimilar to Eli Lilly’s Taltz® (ixekizumab).  The trial has an estimated primary completion date of June 2027 and will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB35 to Taltz® in healthy participants.

The development of an ixekizumab biosimilar by Samsung Bioepis was first reported in November 2025 and was confirmed by Samsung Epis Holdings in January 2026.

Other ixekizumab biosimilars under early development include Celltrion’s CT-P52 (first announced in January 2026; confirmed in February 2026) and Alvotech’s AVT28 (confirmed in February 2026).

On 26 August 2026, Biocon announced that it received marketing authorisation from Japan’s Ministry of Health, Labour and Welfare for its pegfilgrastim biosimilar, referencing Amgen’s Neulasta® (known as G-Lasta® in Japan).  The biosimilar will be exclusively marketed in Japan by Sandoz, with “Global Regulatory Partners Japan” serving as the marketing authorisation holder on Biocon’s behalf.

The Japanese approval comes over 8 years after Biocon’s biosimilar pegfilgrastim, Fulphila®, was approved in the US (approved June 2018, launched July 2018).  Fulphila® has also been approved and launched in other regions, including Europe (approved November 2018), Canada (launched April 2020) and Australia (launched April 2020).

The only other reported pegfilgrastim biosimilar approved in Japan is Kidswell Bio Corporation/Mochida Pharmaceutical’s pegfilgrastim BS Subcutaneous Injection 3.6 mg, which was approved in September 2023.

On 25 August 2026, Celltrion announced that it has launched Omlyclo® 300 mg, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in Europe, commencing in Germany, the UK and France.

Omlyclo® was the first (and remains the only) omalizumab biosimilar to be approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation following in November 2025.  Celltrion commenced its European rollout of Omlyclo® (75 mg/0.5 mL and 150 mg/1 mL) in Norway in September 2025, and completed the launch of those formulations in major European countries including Germany, Spain, the UK and France in November 2025.

The 300 mg formulation of Omlyclo® has also been launched in Korea (30 March 2026) and approved in a number of countries including the US (December 2025) and Canada (January 2026).

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.

Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

On 24 August 2026, Celltrion announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab).  This is the second biosimilar pembrolizumab application filed in Korea, following Samsung Bioepis’ application earlier this month for SB27.

Commencing with its Korean application, Celltrion plans to “sequentially pursue applications for CT-P51 in major global markets”, including the US, EU and Canada.  According to Celltrion, it has a competitive advantage in relation to biosimilar pembrolizumab due to its large-scale in-house production facilities and its strong direct sales distribution network.

Celltrion’s Korean application regarding CT-P51 is based on clinical trial results in 228 patients with melanoma.  In July 2026, Celltrion terminated its Phase 3 trial of CT-P51 in Europe in order to streamline its pembrolizumab development program.  It also recently streamlined its US Phase 3 trial for CT-P51 in patients with untreated metastatic non-squamous non-small cell lung cancer by reducing the number of trial participants.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up.  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

On 21 August 2026, Celltrion announced that it has launched Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in an intravenous (IV) formulation in Japan.

Celltrion’s IV formulation of Steqeyma® was approved in Japan in April 2026, with the subcutaneous formulation launching in July 2025 following its March 2025 approval.  Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, and the IV formulation is additionally approved for Crohn’s Disease.

Celltrion is one of a number of biosimilar competitors that have launched ustekinumab products in Japan, including, Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025) and Samsung Bioepis (May 2026).

On 21 August 2026, Alvotech and Lotus Pharmaceutical announced that they have entered into a licensing and commercialisation agreement for Alvotech’s AVT34, biosimilar to AstraZeneca’s Imfinzi® (durvalumab), and AVT87, biosimilar to Roche/Genentech’s Hemlibra® (emicizumab), in the US and across eight Asian markets.

The agreement reportedly has a potential value for Alvotech of up to approximately US$150 million, based on upfront and milestone payments and ongoing revenues from the supply of commercial product.

Under the agreement, Taiwan-based Lotus has semi-exclusive commercialisation rights in the US, and exclusive commercialisation rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia.

Under the semi-exclusive agreement for the US Alvotech will commercialise both AVT34 and AVT87 in parallel to Lotus, with Lotus commercialising the products through its US-based wholly-owned subsidiary, Alvogen.  Alvotech is responsible for development and marketing authorisations in the US, while Lotus has responsibility for local regulatory submissions and commercialisation in Asia.

Alvotech and Alvogen were each founded by Robert Wessman who remains the Chairman of both companies.  Alvogen was acquired by Lotus in December 2025.  Robert Wessman is the Chairman of the Board of Lotus.

Biosimilar development of durvalumab is at a very early stage globally, with Alvotech’s AVT34 being the first announced therapeutic durvalumab biosimilar in development.

Biosimilar emicizumab is being developed by CSPC Pharmaceutical Group, which announced in March 2026 that China’s National Medical Products Administration had approved clinical trials for its biosimilar emicizumab  (SYS6053).  Prestige BioPharma also has a preclinical emicizumab biosimilar in its pipeline.

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 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery.

Opdivo® was previously approved in Taiwan for a number of indications, including, in combination with BMS’ Yervoy® (ipilimumab), for unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and unresectable or metastatic hepatocellular carcinoma, and in combination with cisplatin and gemcitabine, for unresectable or metastatic urothelial carcinoma.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.

On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).

Biocon first launched Yesintek® in the US in February 2025 (in PFS and vial presentations), following Yesintek®’s original FDA approval in November 2024.  The timing of Biocon’s US launch was governed by a US settlement and licence agreement with Janssen (entered in February 2024), including to resolve an Inter Partes Review Petition.

There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Samsung Bioepis’ Pyzchiva® (FDA-approved July 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).