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.

On 8 December 2025, GxP News reported that Russia’s Binnopharm Group and China’s Mabwell have signed a MOU in relation to localising the production of Mabwell’s biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab) in Russia and the EAEU.

The two companies have previously partnered in 2022, with Binnopharm Group obtaining the exclusive rights for the production, registration and sale of Mabwell’s adalimumab and denosumab biosimilars (9MW0113, 9MW0321 and 9MW0311) in Russia and the EAEU.  In January 2024, Mabwell’s adalimumab and denosumab biosimilars were approved for Phase III clinical trials in Russia, where Russian clinical data is required for local marketing, with Binnopharm to conduct and fund the trials.

There are a number of dupilumab biosimilars under development.  A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar.  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, with Alvotech responsible for development, and Advanz responsible for commercialisation.

On 25 November 2025, Sanofi and Regeneron announced that the European Commission has approved an indication extension to Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU.

Dupixent® was also recently approved by the US FDA for CSU in April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

There are a number of dupilumab biosimilars under development.  A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar.  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, with Alvotech responsible for development, and Advanz responsible for commercialisation.

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).  Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024.  Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab).  According to Formycon, preclinical development is completed and it is working on the study design for the planned clinical pharmacokinetic (PK) study in close alignment with the European Medicines Agency (EMA) and the US FDA.

According to Dr. Andreas Seidl, Formycon’s CSO, Formycon believes it will “be able to meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study).”

There are a number of other 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, with Alvotech responsible for development, and Advanz responsible for commercialisation.