On 31 August 2026, South Korean-headquartered Huonslab, a subsidiary of Huons Global, announced that it secured patent registration in Korea, and has filed an international patent application under the Patent Cooperation Treaty (PCT), for its recombinant human-derived hyaluronidase-based formulation conversion platform technology (HyDIFFUZE™), applied to 11 antibody therapeutics.

The antibody formulations to which the HyDIFFUZE™ technology has been applied by Huonslab are pembrolizumab, bevacizumab, isatuximab, durvalumab, cetuximab, risankizumab, dupilumab, obinutuzumab, ramucirumab, donanemab and dostarlimab.

Huonslab was established in 2018 and focuses on the development of innovative drug delivery technologies.  It has a pipeline of biopharmaceutical and peptide drugs, including an early stage denosumab biosimilar, HLB3-013, in addition to its HyDIFFUZE™ technology that uses hyaluronidase to convert intravenous formulations of antibody drugs into subcutaneous injections.

Interest in subcutaneous formulations of antibody drug products is continuing to increase.  MSD is currently engaged in litigation with Halozyme in the US and Europe in relation to Halozyme’s MDASE subcutaneous delivery technology and subcutaneous Keytruda® (pembrolizumab).  A collaboration between Sandoz and Shanghai Henlius Biotech announced earlier in August 2026 provides Sandoz with an option for a recombinant human hyaluronidase (HLXTE-Haase1001) to be used in the development of a subcutaneously administered biosimilar.  At the end of July 2026, it was announced that Celltrion is partnering with Korean-based G2GBIO to convert antibody drugs to subcutaneous formulations.  Alteogen has partnered with a number of companies for the use of its ALT-B4 technology in subcutaneous formulations, including Sanofi, Daiichi Sankyo, and GSK.

On 31 August 2026, Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), in prefilled syringe and autoinjector forms for subcutaneous administration.  Alvotech announced positive results from a PK study for AVT80 in February 2026.

Under a partnership with Teva, Alvotech is responsible for the development and manufacture of AVT80, while Teva is responsible for its US commercialisation.  Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.

Alvotech’s BLA for its intravenous (IV) biosimilar vedolizumab, AVT16, was the first reported vedolizumab biosimilar BLA to be accepted for review by the FDA in May 2026 (announced in June 2026).  Alvotech’s commercialisation partners for AVT16 are Teva in the US and Advanz in the UK, EU and Switzerland.

Polpharma/Fresenius Kabi’s BLA and Marketing Authorisation Application (MAA) for the vedolizumab biosimilar PB016 were accepted for review by the FDA and European Medicines Agency (EMA), respectively, in July 2026.  In both regions, PB016 is delivered in a lyophilised vial for IV administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Other vedolizumab biosimilars are also under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Litigation regarding vedolizumab biosimilars is currently underway in the UK (court applications to revoke Takeda/Millenium patents relating to vedolizumab filed by Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis earlier this year) and the US (BPCIA litigation commenced by Takeda against Polpharma in August 2026).

On 31 August 2026, Taiwan-based Formosa Pharmaceuticals announced that it has submitted a Clinical Trial Application (CTA) to European regulators for a pivotal clinical trial of TSY-110, biosimilar to Roche’s Kadcyla® (trastuzumab emtansine).  Kadcyla® is an antibody drug conjugate (combining Herceptin® with the cytotoxic payload, mertansine), indicated for HER2-positive metastatic and early-stage breast cancer

The clinical trial of TSY-110 will evaluate its safety, tolerability, pharmacokinetics and immunogenicity profile compared with Kadcyla®.  The trial has been designed following regulatory guidance from US and European authorities.

TSY-110 (also known as EG12043) was co-developed by Formosa and EirGenix under a March 2022 agreement.  According to Formosa, TSY-110 is “positioned to become the first biosimilar alternative to Kadcyla® in major regulated markets”.

The first reported Kadcyla® biosimilar anywhere in the world was Zydus’ Ujvira®, which was launched in India in May 2021.  Intas’ trastuzumab emtansine biosimilar received Indian marketing approval in July 2026.

Various trastuzumab emtansine biosimilars are under development including by Biocad (BCD-237; commenced Ph 3 clinical trial enrolment in June 2026) and Zhejiang Hisun Pharmaceutical (HS630; reported results of a nonclinical study of the biosimilar in 2025).

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, DualityBio announced that it has entered into a global collaboration and licence agreement with Genentech to develop antibody-drug conjugates (ADCs) utilising the “DualityBio Unique Payload Antibody Conjugate” (DUPAC) platform.

Under the agreement, China-based Duality will generate and develop ADCs against US-based Genentech’s defined oncology targets using payloads from the DUPAC platform and will lead discovery and early global clinical development.  Genentech will receive an exclusive global licence and will assume sole responsibility for clinical development and commercialisation after Phase 1a.

Duality will receive an upfront payment of US$45 million and is eligible to receive more than US$1 billion in aggregate milestone payments, plus tiered royalties on annual net sales of approved products.

Between 2023 and 2025, Duality entered into licence and commercialisation agreements with BioNTech, GSK, BeOne Medicines (formally BeiGene) and Avenzo Therapeutics in relation to Duality’s ADCs.  In April 2023, Duality and BioNTech entered into an exclusive licence and collaboration agreement for two ADC assets (DB-1303 and DB-1311).  In July 2023, Duality and BeOne Medicines (formally BeiGene) entered into an exclusive option for a global clinical and commercial licence agreement for an ADC for patients with solid tumours.  In December 2024, Duality and GSK entered into an exclusive option to obtain a licence to develop and commercialise DB-1324.  In January 2025, Duality and Avenzo Therapeutics entered into an exclusive global licence and commercialisation agreement for AVZO-1418/DB-1418.

On 28 August 2026, the FDA announced that it approved Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC) in children aged 2 years and older. The new paediatric UC indication follows the US approval of Stelara® for paediatric Crohn’s disease in April 2026.

Stelara® is facing significant competition from biosimilars globally, including in the US, following settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Samsung Bioepis/Sandoz (Pyzchiva® launched February 2025), Celltrion (Steqeyma® launched March 2025) and Fresenius Kabi and Formycon (Otulfi® launched March 2025).  Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (August 2025) and Bio-Thera/Hikma’s Starjemza™ (November 2025).

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, Takeda commenced BPCIA proceedings against Polpharma in the US District Court for the District of New Jersey in relation to Polpharma’s PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  Takeda alleges infringement of six US patents relating to vedolizumab; its administration to treat inflammatory bowel disease, ulcerative colitis, and Crohn’s disease; and its formulation and method of manufacture (US patent numbers 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969).

The US litigation follows UK litigation commenced earlier this year against Takeda by a number of biosimilar manufacturers seeking to clear the way for their vedolizumab products, as discussed further below.

The BPCIA proceedings arise from Polpharma’s submission of an abbreviated Biologics License Application (aBLA) to the FDA, seeking approval to market its vedolizumab biosimilar for intravenous (IV) infusion.  While the date of the aBLA submission is confidential, Takeda’s complaint discloses that Polpharma provided a Notice of Commercial Marketing to Takeda on 18 June 2026, confirming that Polpharma and its commercial marketing partner, Fresenius Kabi, will commence commercial marketing of PB016 (IV) no earlier than 15 December 2026 (being 180 days from the date of the notice).  However, according to the complaint, Polpharma’s counsel informed counsel for Takeda that approval of the aBLA is expected in May 2027.  Takeda is seeking remedies including preliminary and permanent injunctions to restrain the importation and sale of PB016 in the US, and damages.

PB016 was developed by Polpharma Biologics and Fresenius Kabi holds the exclusive commercialisation rights (excluding the MENA region) under a global licensing agreement announced in August 2025.  Polpharma entered into a licensing agreement with MS Pharma for commercialisation of PB016 (and other biosimilars) in the MENA region in September 2025.

Polpharma announced on 31 July 2026 that its aBLA for PB016 was accepted for review by the FDA in a lyophilised vial for IV administration, indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.  Acceptance of the marketing authorisation application for PB016 by the European Medicines Agency was announced on the same date.

The first FDA acceptance of a BLA for a vedolizumab biosimilar was in June 2026, for Alvotech’s AVT16 (lyophilised vial for IV administration).  AVT16 will be commercialised by Teva under a strategic partnership entered in August 2020 and expanded in 2023.  Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.

Other vedolizumab biosimilars are under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Fresenius Kabi, Advanz Pharma (Alvotech’s UK/EU commercialisation partner), Accord Healthcare (an Intas subsidiary) and Samsung Bioepis (together, Biosimilar Claimants) each commenced proceedings earlier this year in the High Court of England and Wales against Millennium Pharmaceuticals, a Takeda subsidiary.  The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products and have applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations.  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations for vedolizumab (EP (UK) 2704798 and 4403579).

On 26 August 2026, OncLive reported that Chia Tai Tianqing Pharmaceutical’s TQB2440 showed equivalent efficacy to its reference drug, Roche/Genentech’s Perjeta® (pertuzumab), in a Phase 3 clinical trial, when combined with trastuzumab and docetaxel as neoadjuvant therapy for patients with oestrogen receptor/progesterone receptor–negative, HER2-positive early or locally advanced breast cancer.

The study was first reported in ESMO Open in January 2026 and was conducted in 56 centres in China between 21 October 2020, and 14 August 2022.  The study concluded that the safety, pharmacokinetic, and immunogenicity profiles of TQB2440 and reference pertuzumab were similar.

Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).  Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.

In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan.  This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.

Multiple pertuzumab biosimilars have been the subject of litigation by Roche and Genentech.  Recently, BPCIA proceedings relating to 28 US patents were commenced against Biocon relating to its pertuzumab biosimilar, Bmab 1500.  Roche and Genentech also filed BPCIA proceedings in August 2025 against Shanghai Henlius and Organon in relation to Poherdy®.  Those proceedings were settled in January 2026 on confidential terms.  In March 2026, Genentech commenced legal proceedings against Biocad before the Moscow Arbitration Court alleging patent infringement due to Biocad’s Pertuvia™.  Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, has been running in India since the Indian approval of the product in June 2024.

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.