On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications.  Celltrion is also planning regulatory filings for CT-P55 in the US, Europe and Korea.

According to Celltrion, its first biosimilar secukinumab application was filed in Canada on the basis that it is a “pro-biosimilar nation” and pursues “policies to promote the introduction of biosimilars and [improve] its regulatory environment”.

The Canadian application is based on Celltrion’s Phase 1 trials, results of which were presented in September 2025.  In February 2026, Celltrion received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.

Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.

The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation to the aflibercept biosimilar announced in January 2026.  Under the agreement, 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 Opuviz™ 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).

The European launch of Opuviz™ comes two weeks after Formycon/Klinge launched their aflibercept biosimilar, FYB203, in key European markets.  Aflibercept biosimilars have also been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025).  Settlement agreements between Regeneron/Bayer and other companies permit further 2026 EU biosimilar aflibercept launches, including for Alvotech and Biocon.

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as Poherdy® in the US and Europe), biosimilar to Roche’s Perjeta® (pertuzumab).  Hanbeiyou® is approved for all Perjeta® indications.

HLX11/Poherdy® was the first pertuzumab biosimilar approved in the US (November 2025) and EU (April 2026).  In the US, a BPCIA patent challenge by Genentech/Roche against Henlius/Organon regarding Poherdy® was settled in January 2026 on confidential terms, with no details of any planned US launch of Poherdy® being disclosed to date.

Organon has exclusive global commercialisation rights to HLX11, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 deal.

Pertuzumab biosimilars have been approved in India, including Intas’ biosimilar (December 2024, subject to submission of further studies), 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.  Pertuzumab biosimilars are also under development by Sandoz and EirGenix.  In February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).  The subcutaneous (SC) application was submitted for all Herceptin® SC indications, including the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This follows Celltrion’s announcement on 30 April 2026 that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC.  The timing of these applications aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approval of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.  According to Celltrion, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.

There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage.  In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab) label to include data demonstrating that the treatment inhibits the progression of structural joint damage in adults with active psoriatic arthritis (PsA).  The label update positions Tremfya® as the only IL-23 inhibitor with demonstrated structural inhibition in its label, offering patients with active PsA a first-line treatment option that provides both symptom control and protection against irreversible joint damage.

Tremfya® was first approved in the US for moderate-to-severe plaque psoriasis (PsO) in July 2017.  Since then, its approved indications have been significantly expanded: the FDA approved Tremfya® for moderately to severely active ulcerative colitis (UC) in September 2024, followed by approval of a subcutaneous induction regimen for UC in September 2025, and approval for moderately to severely active Crohn’s disease in March 2025.  In September 2025, the FDA also extended Tremfya®’s PsO and PsA approvals to children aged six and older weighing at least 40 kg.

No guselkumab biosimilars have been approved in any major market, and biosimilar development of guselkumab appears to be at early stages globally.  In September 2025, Polpharma Biologics and MS Pharma entered into a licensing agreement for the commercialisation of PB019 (biosimilar guselkumab) in the Middle East and North Africa (MENA) region.  Alvotech has a proposed guselkumab biosimilar in development (partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland), and Samsung Bioepis announced in January 2026 that it has biosimilar guselkumab in development.

On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the multiple sclerosis drug market.

Biogen markets Tysabri® (natalizumab) for the treatment of multiple sclerosis.  Treatment with natalizumab can cause a rare but serious side effect, which means that patients are required to undergo a specific test (the ‘anti-JCV test’) before and during treatment with natalizumab.  AGCM is concerned that Biogen is using its anti-JCV Stratify test to exclude or limit competition from Sandoz by tying the use of the test to the purchase of Tysabri®, and refusing to make it commercially available to patients treated with Sandoz’s natalizumab product, Tyruko®.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.  Tyruko® is approved in multiple markets, including the US (August 2023), Europe (September 2023) and Australia (April 2025).

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The BLAs seek approval for all indications of the reference products.

Days earlier, on 26 May 2026, Boan Biotech announced that China’s National Medical Products Administration (NMPA) approved its supplemental application for Boluojia® (BA11021) (denosumab injection 120 mg), biosimilar to Xgeva®, for the treatment of patients with bone metastases from solid tumours or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery.  Boluojia® was first approved in China in May 2024 for the treatment of giant cell tumour of bone.

Boan Biotech’s Boyoubei® (BA6101) was approved in China in November 2022 and in Bolivia in January 2026.  In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  According to Boan Biotech, regulatory submissions for its denosumab biosimilars are also planned for Europe and Japan, among other regions.

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC was approved by the FDA in February 2026, shortly after the trial was approved in China.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval from the NMPA in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD.  The FDR process is an appeal mechanism that permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.

In December 2025, the FDA issued a Complete Response Letter (CRL) for the second resubmission of ONS-5010/Lytenava™, recommending that additional confirmatory evidence be provided to support Outlook’s application, though it did not clarify what type of evidence would be acceptable.  Outlook subsequently attended a Type A meeting with the FDA in March 2026 to discuss the CRL and then submitted its Formal Dispute Resolution Request in April 2026.

In its appeal decision, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava™ for the treatment of wet AMD, despite the earlier CRL.  The decision directs the FDA’s Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) to work with Outlook Therapeutics to reach agreement on final labelling.

Outlook Therapeutics expects to resubmit the BLA for ONS-5010/Lytenava™ in June 2026.  If approved, ONS-5010/Lytenava™ would be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the product, while Argentina-based Tuteur will be responsible for the commercialisation, marketing and distribution across Latin America, excluding Brazil.

The unnamed biosimilar is currently in development, with the companies anticipating a regulatory submission to be filed within the next three years.

In December 2025, Polpharma Biologics entered into an exclusive licensing agreement with Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.  This deal followed a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®).  In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).