About dupilumab
Dupilumab manufacturers are currently limited to the originators, Regeneron and Sanofi, which sell it as Dupixent, while several biosimilar developers are in early or mid-stage development. Dupilumab is a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 signalling, two key drivers of type 2 inflammation. It is approved for atopic dermatitis, asthma, COPD, nasal polyps and several other conditions. Companies interested in dupilumab can explore biosimilar development or co-development partnerships.
Dupilumab key facts
|
Property |
Dupilumab |
|---|---|
|
INN |
Dupilumab |
|
Molecule type |
Fully human IgG4 monoclonal antibody against IL-4 receptor alpha |
|
ATC code |
D11AH05 |
|
Drug class |
Interleukin-4/13 inhibitor (biologic) |
|
Brand name |
Dupixent |
|
Originators |
Regeneron and Sanofi (global collaboration) |
|
Dosage forms and strengths |
Prefilled syringes and pens: 300 mg/2 ml, 200 mg/1.14 ml; 100 mg prefilled syringe |
|
Indications (US) |
Atopic dermatitis; asthma; chronic rhinosinusitis with nasal polyps; eosinophilic esophagitis; prurigo nodularis; COPD; chronic spontaneous urticaria; bullous pemphigoid; allergic fungal rhinosinusitis |
|
First approval |
US FDA, March 2017 (atopic dermatitis) |
|
Recent US approvals |
COPD (2024); chronic spontaneous urticaria (April 2025; children 2–11, April 2026); bullous pemphigoid (June 2025); allergic fungal rhinosinusitis (February 2026) |
|
Global reach |
Approved in more than 60 countries; more than 1 million patients treated |
|
Biosimilar status |
None approved; in development by several companies |
Dupilumab manufacturers and licensing history
Regeneron discovered dupilumab using its VelocImmune technology, and it is developed jointly with Sanofi. The FDA approved Dupixent in March 2017 for atopic dermatitis. Approvals have since expanded to asthma, nasal polyps, eosinophilic esophagitis, prurigo nodularis and COPD.
More recent approvals include chronic spontaneous urticaria in April 2025, bullous pemphigoid in June 2025, and allergic fungal rhinosinusitis in February 2026. In April 2026, the EU and US approved it for chronic spontaneous urticaria in children aged 2 to 11.
No biosimilar is approved. Developers include Samsung Bioepis, Bio-Thera (with SteinCares for Latin America), Alvotech (with Advanz for Europe), Binnopharm and Mabwell. In China, CSPC received approval to start clinical trials in 2025. Companies considering biosimilars need advanced antibody manufacturing and a clear view of patent expiry.
Dupilumab dosage forms and dossier types
Dupilumab is supplied as solution for subcutaneous injection in prefilled syringes and pens, in three strengths.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Dupilumab prefilled pen / syringe |
300 mg/2 ml |
BLA; EU centralised MAA |
Main adult strength |
|
Dupilumab prefilled pen / syringe |
200 mg/1.14 ml |
BLA; EU centralised MAA |
Adults and children |
|
Dupilumab prefilled syringe |
100 mg/0.67 ml |
BLA; EU centralised MAA |
Young children |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
Future 351(k) biosimilar |
Patent expiry; interchangeability data |
|
European Union |
Future biosimilar MAA |
Data protection and SPC expiry |
|
China, Latin America, other |
National biosimilar pathways |
Biosimilar programmes already started |
Dupilumab regulatory and patent status
The FDA approved dupilumab in March 2017, and the EU later in 2017. It is now approved in more than 60 countries for one or more indications. Dupilumab is protected by patents expected to run into the 2030s, and no biosimilar is approved. Biosimilar developers should check US, EU and national patent registers before planning development.
Dupilumab mechanism of action and therapeutic use
Dupilumab binds to the IL-4 receptor alpha subunit, which blocks signalling by both interleukin-4 and interleukin-13. These cytokines drive type 2 inflammation, which causes itching, skin lesions, airway inflammation and mucus. Dupilumab is given by subcutaneous injection every 2 or 4 weeks for atopic dermatitis, asthma, COPD, nasal polyps and other type 2 inflammatory diseases.
Dupilumab licensing and sourcing
Dupilumab is currently available only from Regeneron and Sanofi. Companies interested in this molecule usually explore biosimilar development, co-development or regional commercialisation partnerships. Current offers and contacts are listed among the dupilumab manufacturers on Pipelinepharma.
Frequently asked questions about dupilumab
Who manufactures dupilumab? Regeneron and Sanofi make dupilumab and sell it as Dupixent.
Is there a biosimilar of dupilumab? No. No dupilumab biosimilar is approved, but several companies, including Samsung Bioepis, Bio-Thera and Alvotech, are developing one.
What is dupilumab used for? Dupilumab is used for atopic dermatitis, asthma, COPD, nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, bullous pemphigoid and allergic fungal rhinosinusitis.
What forms and strengths of dupilumab are available? Dupilumab is available as 300 mg, 200 mg and 100 mg prefilled syringes, and 300 mg and 200 mg prefilled pens.
When was dupilumab first approved? The US FDA approved dupilumab in March 2017 for atopic dermatitis.
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