FDA approves Yesintek single-dose autoinjector for chronic inflammatory diseases
- nuaxia
- 2 days ago
- 2 min read
The supplemental approval introduces a new self-injection option for patients receiving Yesintek across its approved autoimmune indications without changing the medicine's existing therapeutic uses.
The US Food and Drug Administration (FDA) has granted supplemental approval for Yesintek® (ustekinumab-kfce) 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors for patients receiving the biosimilar across its previously approved indications, including plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
The approval expands administration options by introducing an autoinjector presentation while maintaining the medicine's existing approved indications and dosing regimens.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Yesintek® (ustekinumab-kfce) |
Indication | Supplemental approval of 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors for the existing approved indications: moderate to severe plaque psoriasis and active psoriatic arthritis in adults and paediatric patients aged six years and older, and moderately to severely active Crohn's disease and ulcerative colitis in adults. (FDA Access Data) |
Therapy Area(s) | Immunology; Dermatology; Gastroenterology; Rheumatology |
Geography | United States (FDA) |
What Happened | On 18 August 2026, the FDA granted supplemental approval for Yesintek® single-dose prefilled autoinjectors in 45 mg/0.5 mL and 90 mg/mL presentations. Yesintek, a biosimilar to Stelara® (ustekinumab), was originally approved in 2024. The latest approval authorises a new delivery format rather than a new indication, giving eligible patients another administration option while retaining the product's existing approved uses. (Biocon) |
Why It Matters | The approval provides an additional method of administering Yesintek that may better suit some patients and care settings while preserving the same clinical indications. It expands treatment flexibility without altering the medicine's established efficacy, safety profile or approved therapeutic uses. (Biocon) |
Supporting Context | Yesintek is an interchangeable biosimilar to Stelara® and is approved for multiple chronic inflammatory conditions mediated by interleukin-12 and interleukin-23. The autoinjector complements the existing prefilled syringe and vial presentations already available for the product. (FDA Access Data) |
Key Takeaway | FDA approval adds a new autoinjector presentation for Yesintek, expanding administration options while maintaining the medicine's existing approved indications. (Biocon) |
What to Watch | Commercial rollout of the autoinjector presentation in the United States and uptake among patients and healthcare providers using ustekinumab biosimilars. (Biocon) |
Primary Source | |
Relevant Date | 18 August 2026 |
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