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).

On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.

Under the agreement, China-based Bio-Thera is responsible for the development, manufacturing and supply of BAT2406, while Saudi-based Avalon Pharma is responsible for seeking regulatory approvals and commercialisation.  BAT2406 is currently in Phase I clinical trials.

Bio-Thera has also partnered with Costa-Rican-based SteinCares on BAT2406, entering an exclusive licence and commercialisation agreement in June 2025 for LATAM.

Biosimilar dupilumab is under development by multiple companies, including Samsung Bioepis (SB33 in pre-clinical development), Alvotech and Advanz (AVT19 in early development), Binnopharm and Mabwell (MOU announced December 2025 for Russia), Daewoong Pharmaceutical and Chime Biologics (agreement announced June 2026), and Formycon (FYB208 in early development).

In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

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 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation collaboration agreement, covering up to 10 biosimilars (including monoclonal antibodies and/or antibody-drug conjugates).

There are three products initially covered by the agreement:

• HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), which is currently in clinical development;
• HLX16, biosimilar to Amgen’s Repatha® (evolocumab), which is in “technical development”; and
• biosimilar belimumab, referencing GSK’s Benlysta®, which is in “early development”.

Sandoz also has an option for HLXTE-HAase1001, a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar.

Under the terms of the agreement, Henlius will be responsible for biosimilar development and manufacturing, while Sandoz will have certain commercialisation rights for the biosimilars outside of China.  For HLX05-N, Sandoz will have exclusive commercialisation rights in the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, and semi-exclusive rights in certain Asian and other countries.  The exclusive commercialisation territory for HLX16 and the belimumab biosimilar includes all markets worldwide outside China.

Sandoz will pay Henlius an upfront payment, milestone payments and a non-refundable option fee totalling up to US $322 million, with Henlius expected to receive US $100.5 million in 2026.

The companies have previously partnered on HLX13, biosimilar to BMS’ Yervoy® (ipilimumab).  Under an agreement announced in April 2025, Henlius is developing and manufacturing HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan, and Australia.  HLX13 entered clinical trials in November 2025.

On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of patients with recurrent and metastatic cervical cancer who have previously received platinum based chemotherapy.

Fast-track designation is designed to accelerate the development and review of drugs intended to treat serious diseases and address unmet medical needs.  A company that receives fast track designation for a drug may have more frequent meetings with FDA regarding the development plan and collection of data needed to support drug approval, may submit sections of its BLA/NDA for “rolling review” and the drug may be eligible for accelerated approval and priority review if relevant criteria are met.

Celltrion has two other ADCs, CT-P70 and CT-P71, which have also secured FDA fast-track designation.  CT-P70 is being developed for the treatment of non-small cell lung cancer (NSCLC), while CT-P71 is undergoing evaluation in patients with locally advanced or metastatic urothelial carcinoma.  All three ADCs are in phase 1 clinical trials.