US FDA approves Biocon’s single-dose prefilled autoinjector for YESINTEK (ustekinumab-kfce) in 45 mg and 90 mg doses for plaque psoriasis, PsA, IBD, and CD.
Written by: Kirti Kumbhar, M. Pharm (QA)
Reviewed by: Pharmacally Editorial Team
Biocon Limited announced on August 18, 2026, that its U.S. subsidiary received supplemental U.S. Food and Drug Administration (FDA) approval for single-dose prefilled autoinjector presentations of YESINTEK® (ustekinumab-kfce). The approval covers 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, adding a new delivery format to the existing YESINTEK product portfolio.
YESINTEK was originally approved by the U.S. FDA on November 29, 2024, as a biosimilar to Stelara® (ustekinumab). The August 2026 action is a supplemental approval for the autoinjector presentation and does not introduce a new therapeutic indication.
Approved Uses of YESINTEK
YESINTEK is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years of age and older. It is also indicated for moderately to severely active Crohn’s disease and ulcerative colitis in adults.
Ustekinumab is a monoclonal antibody that targets the p40 protein subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby blocking signaling mediated by these cytokines. This mechanism underlies its use across the approved inflammatory and autoimmune conditions.
New Autoinjector Presentation
The FDA approval adds two single-dose prefilled autoinjector presentations:
- YESINTEK 45 mg/0.5 mL
- YESINTEK 90 mg/mL
The new presentation provides another option for delivering YESINTEK by subcutaneous injection. Biocon said the autoinjector offers patients another important treatment option and supports more tailored treatment approaches across different care settings and patient needs.
The approval should therefore be viewed primarily as an expansion of the product’s delivery options, rather than a new clinical or therapeutic milestone. It does not change the established approved indications of YESINTEK.
Significance for Biocon
The supplemental FDA approval expands Biocon’s immunology portfolio in the United States by adding an autoinjector presentation to its existing YESINTEK offerings. The company said the approval also reinforces its commitment to improving access to affordable medicines for patients globally.
For patients receiving YESINTEK for its approved indications, the newly approved autoinjector provides an additional product presentation. The appropriate strength, dose, administration schedule, and treatment setting remain dependent on the approved indication and individual patient requirements.
Overall, the August 2026 FDA action expands how YESINTEK can be delivered, while maintaining its existing therapeutic indications and role as an ustekinumab biosimilar.
References
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.
