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Biocon Biologics unveils Yesintek biosimilar to Stelara in US
A new FDA‑approved ustekinumab biosimilar (YESINTEK) is now available in the US for Crohn’s disease and ulcerative colitis, which may increase treatment options and lower costs. Coverage and copay support at launch could improve access for some patients.
Clinicians and patients may see a new formulary and switching option to discuss with care teams.
Adults with Crohn’s disease or ulcerative colitis who are current or potential ustekinumab users, clinicians prescribing biologics, pharmacists, and patient advocates focused on medication access and affordability.
What To Know
Biocon Biologics announced US availability of YESINTEK (ustekinumab‑kfce), a biosimilar to Stelara (ustekinumab), approved by the FDA in December 2024.
The article states YESINTEK is approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, and will be offered in the same formulations and dosing presentations as the originator.
The report notes commercial payer coverage at launch and a patient assistance/copay program that may reduce out‑of‑pocket costs for eligible patients. What this means: YESINTEK is presented as an alternative to Stelara with the same labeled indications and dosing forms.
The company and a patient-advocacy representative highlight increased access and affordability. The article summarizes that clinical studies showed similar pharmacokinetics, safety, efficacy, and immunogenicity to Stelara and that the product received FDA approval in Dec 2024.
Practical points: availability, payer coverage, and a copay assistance program are emphasized; clinicians and patients switching therapies should consult prescribing information and payor policies. This piece is a news release-style report on a new biosimilar launch rather than independent clinical data.
This is a company announcement summarizing FDA approval and launch details; it references clinical comparability studies but does not provide independent study data. Individual treatment decisions, switching, and coverage depend on clinician judgment and payer policies. Read the FDA label and discuss with your care team for personalized guidance.
