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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In the STEP UP trial, the higher dose of Wegovy® (semaglutide 7.2 mg) demonstrated a mean weight loss of 21%, with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1 'The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide's established safety profile. This may offer another option to people who do not attain their weight goals,' said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. 'We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.' STEP UP co-primary endpoints at 72 weeks *1 : semaglutide 7.2 mg semaglutide 2.4 mg PlaceboWeight loss 20.7% 17.5% 2.4% 5% or more weight loss 93.2% 92.5% 35.7% When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo. 'With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. 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These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'is,' 'can,' 'may,' 'will,' and 'believe' and include statements argenx makes concerning argenx's aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its belief that the approval of VYVGART SC for the treatment of CIDP may bring meaningful functional improvements to patients; the timing of access to an effective novel therapy for CIDP patients and physicians across Europe; and the potential of efgartigimod in IgG-mediated autoimmune diseases. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. 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Business Wire
3 days ago
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