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Cure8 news brief
Biocon Biologics launches Yesintek biosimilar to Stelara in US
Medications
Ustekinumab
Biosimilars
IL-12/23 inhibitor
Regulatory Update
Adult patients
Patients On Biologics
Clinicians
Why This Matters
A new FDA‑approved biosimilar to ustekinumab is now available in the U.S., which may increase treatment options and lower out‑of‑pocket costs for people with Crohn’s disease or ulcerative colitis. The article highlights payer coverage and patient assistance at launch.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis who take or are considering ustekinumab, clinicians who prescribe biologics, specialty pharmacists, and patient advocates.
Study Snapshot
Story typeCompany update
Evidence typeRegulatory update
Source depthFull source text
What To Know
Biocon Biologics has launched Yesintek (ustekinumab-kfce), a biosimilar to Stelara (ustekinumab), in the United States.
The company says Yesintek is approved for Crohn’s disease and ulcerative colitis (as well as psoriasis and psoriatic arthritis) and will be offered in the same formulations and dosing presentations as the originator, with commercial payer coverage at launch and patient assistance/copay support.
Yesintek is described as a monoclonal antibody that targets IL-12 and IL-23 pathways and the company reports clinical studies showed similar pharmacokinetics, safety, efficacy, and immunogenicity to Stelara. The article notes FDA approval was granted in December 2024. The launch is presented as increasing access to a lower-cost option for eligible patients.
If you currently use ustekinumab (Stelara) or are considering it, this may affect insurance coverage, copay costs, or available patient-support programs. Talk with your prescribing clinician or specialty pharmacy about whether Yesintek is an option for you and how switching or starting treatment would be handled in your care setting.
Keep In Mind
This is a product launch and regulatory update reporting FDA approval and commercial availability; it does not provide new clinical trial data beyond stating biosimilarity. Any decision to switch products should be made with a healthcare provider and based on coverage, clinical circumstances, and available support programs.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationpharmabiz.com
Indexed viaBing News
Source typeCompany update
PublishedFeb 25, 2025, 2:10 AM
Content availableFull source text
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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