Biocon Biologics receives UK MHRA approval for YESINTEK, Biosimilar Ustekinumab
By Aman Shukla Published on May 25, 2025, 14:12 IST
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for YESINTEK®, a biosimilar of Ustekinumab.
YESINTEK® is approved for use in adults and children aged 6 years and older with moderate to severe plaque psoriasis. It is also indicated for adults with active psoriatic arthritis and moderately to severely active Crohn's disease.
The approval follows clinical trials that demonstrated comparable safety and efficacy between YESINTEK® and the reference biologic product. This outcome supports the use of YESINTEK® as a treatment option aligned with current therapeutic standards.
The MHRA authorisation enables the marketing of YESINTEK® in the United Kingdom. In parallel, Biocon Biologics also recently received marketing authorisation for Ustekinumab from the European Commission (EC), which allows its commercialisation across all European Union (EU) member states and countries in the European Economic Area (EEA).
Biocon Biologics continues its efforts to expand access to biosimilar medicines in regulated markets through strategic approvals and product launches.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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