On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it announced in November 2019 for its ALT-B4 technology with an “undisclosed” pharmaceutical company was a deal with Sanofi regarding development of a high-dose subcutaneous formulation of Dupixent® (dupilumab).  ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.

The Sanofi deal was said by Alteogen in 2019 to potentially be worth up to USD 1.37 billion.  It has been disclosed that Sanofi paid USD13 million upfront in December 2019 and made two subsequent milestone payments, one in March 2020 for an undisclosed amount and a second of USD3 million in April 2023.  No details about the clinical stage of the development have been announced.

Alteogen has since partnered with a number of companies for the use of ALT-B4 in the subcutaneous formulations.  In November 2024, Alteogen signed an exclusive US$300 million licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous injection form of Enhertu® (trastuzumab deruxtecan).  In January 2026, Alteogen entered an exclusive licence agreement with Tesaro, a GSK subsidiary, for the use of ALT-B4 in the development and commercialisation of a subcutaneous formulation of dostarlimab.

Alteogen collaborates with MSD on subcutaneous Keytruda® (pembrolizumab).  MSD’s subcutaneous pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications and has also been approved in Europe (November 2025), Canada (February 2026) and Korea (May 2026).

In January 2023, Alteogen entered into an exclusive agreement with Sandoz for the use of ALT-B4 to develop a subcutaneous version of an undisclosed Sandoz biosimilar product, with an option for Sandoz to licence the Alteogen technology for two further products.

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation (CDMO), Chime Biologics, announced that they have entered a strategic partnership agreement for the development, manufacture and commercialisation of a biosimilar of Sanofi/Regeneron’s Dupixent® (dupilumab).

Under the agreement, Chime will support the development and manufacture of Daewoong’s dupilumab biosimilar, while both companies will collaborate on commercialisation.

Although Daewoong has previously partnered on biosimilars in the Korean market (for example, promoting and launching Celltrion’s denosumab biosimilars in Korea), the dupilumab agreement with Chime is intended to be the foundation of its biologics expansion strategy, building the Dupixent® biosimilar into a global product.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz, Binnopharm and Mabwell and Amneal.  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).

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027.  This includes:

• biosimilars that are already on the market: Alymsys® (bevacizumab) (FDA-approved April 2022, referencing Avastin®), Releuko® (filgrastim) (FDA-approved March 2022, referencing Neupogen®), Fylnetra® (pegfilgrastim) (FDA-approved May 2022, referencing Amgen’s Neulasta®); and
• those which are yet to launch: Boncresa™ and Ozilutus™ (denosumab) (FDA-approved December 2025 in partnership with mAbxience, referencing Amgen’s Prolia® and Xgeva®) and omalizumab biosimilar, ADL018 (FDA approval pending, under licence with Alvotech, referencing Genentech/Novartis’ Xolair®).

Amneal is also expecting approvals for 6+ advanced pipeline biosimilar products in 2028-2030, including abatacept (referencing BMS’ Orencia®) certolizumab (UCB’s Cimzia®), pembrolizumab (MSD’s Keytruda®), nivolumab (BMS’ Opdivo®) and dulaglutide (Eli Lilly’s Trulicity®).

In 2030+, Amneal is planning for 10+ pipeline products to be approved, including biosimilars of dupilumab (referencing Regeneron/Sanofi’s Dupixent®), risankizumab (referencing AbbVie’s Skyrizi®) and guselkumab (referencing Janssen’s Tremfya®).

Amneal presently intends to commercialise the biosimilars itself in the US and India, with a partnership model being employed in the rest of the world.

On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) and inadequate response to histamine-1 antihistamine (H1AH) treatment.  This approval is the fifth indication of Dupixent® for young children in the US and follows EU approval for the same indication earlier this month.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz and Binnopharm and Mabwell.  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 13 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the European Commission for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihistamines and who are naive to IgE therapy for CSU.  The approval follows a positive CHMP opinion for the indication in February 2026.

The existing CSU indication in Europe (approved in November 2025) had covered adults and adolescents (12 years and above).  According to Regeneron, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz and Binnopharm and Mabwell.  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.

On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent^® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP).  Dupixent® is also approved in Japan for certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD).

Regeneron and Sanofi continue to roll out new indications for Dupixent®, most recently receiving a positive recommendation by EMA’s CHMP in February 2026 for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU), and FDA approval in the same month for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) where there has been a history of sino-nasal surgery.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, and Alvotech and Advanz.  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.

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sanofi/Regeneron’s Dupixent® (dupilumab) received a positive recommendation for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU).  The existing CSU indication in Europe (approved in November 2025) covers adults and adolescents (12 years and above).  According to Regeneron’s press release, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

The CHMP also recommended indication of MSD’s Keytruda® (pembrolizumab), in combination with paclitaxel (with/without bevacizumab), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in certain adults.

Janssen’s Stelara® (ustekinumab) received a recommendation for a change to its indication for paediatric Crohn’s disease for children from 2 years of age, from the current indication of paediatric patients weighing at least 40 kg.

Biosimilar launches, approvals and/or development are well underway for each of dupilumab, pembrolizumab and ustekinumab:

• Companies with dupilumab biosimilars in development include Alvotech, Samsung Bioepis, Formycon, Mabwell, Chong Kun Dang. CSPC Pharmaceutical, and Bio-Thera Solutions.
• Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.
• Ustekinumab biosimilars were launched in Europe in July 2024 by STADA/Alvotech (Uzpruvo®) and Sandoz (Pyzchiva®). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 24 February 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.  Dupixent® is the first and only treatment approved for AFRS in the US.

There are a number of companies with dupilumab biosimilars under development.  For example, Alvotech is developing AVT19 (dupilumab), and has entered into partnership agreements with Advanz in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.

In January 2026, it was announced that Samsung Bioepis had added a dupilumab biosimilar to its pipeline.  In the same month, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab). CSPC Pharmaceutical had earlier announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.

In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.  It was also reported in December 2025 that Russia’s Binnopharm Group and China’s Mabwell signed a MOU in relation to localising the production of Mabwell’s dupilumab biosimilar in Russia and the EAEU.

At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

The announcement confirms the November 2025 report that Samsung Bioepis had commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), with the biosimilar in the early development stage in preparation for preclinical trials.  The same report had also indicated that Samsung Bioepis is developing biosimilars to Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).

Samsung Bioepis has launched 11 biosimilars to 10 INNs on market around the world and has a biosimilar to MSD’s Keytruda® (pembrolizumab), (SB27) in phase 1 and 3 clinical trials (commenced April 2024).  The company is aiming to have 20 biosimilars in its portfolio by 2030.

At the J.P. Morgan Conference, Samsung Epis also announced that the FDA has approved Samsung Bioepis’ investigational new drug application (IND) for SBE303, an antibody-drug conjugate, which is expected to enter a Phase 1 first-in-human clinical trial in patients with advanced refractory solid tumours this year.

There are a number of companies with dupilumab biosimilars under 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 June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.  Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.

Biosimilar development of guselkumab is also underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

Biosimilars to Takeda’s Entyvio® (vedolizumab) are in development by at least Alvotech (Phase 3 clinical trial for AVT16 commenced September 2024), Intas Pharmaceuticals (approval from India’s CDSCO for a Phase 1 bioequivalence study of INTP53 obtained in February 2025) and Polpharma Biologics (which entered into licensing agreements with Fresenius Kabi and MS Pharma for commercialisation of PB016 in August and September 2025).

Ocrelizumab biosimilars (referencing Roche’s Ocrevus®) are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), Amgen (Phase III trial reported in January 2025) and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023).

On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its phase 1 clinical trial protocol for CKD-706, biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab).

According to the report, Chong Kun Dang intends to conduct a European-based clinical trial to demonstrate pharmacokinetic equivalence between CKD-706 and Dupixent® in healthy adults, as well as to assess pharmacodynamics, safety and immunogenicity.

There are a number of dupilumab biosimilars under development.  Alvotech and Advanz Pharma entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of dupilumab (among other biosimilars), in Europe and other regions.

In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America.  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.

As reported in November 2025, and confirmed at the J.P. Morgan Health Conference in January 2026, Samsung Bioepis is developing a dupilumab biosimilar.  It was also reported in December 2025 that Russia’s Binnopharm Group and China’s Mabwell signed a MOU in relation to localising the production of Mabwell’s dupilumab biosimilar in Russia and the EAEU.