Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.
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Biocon Biologics, a subsidiary of India-based Biocon, announced on May 25, 2025, that its biosimilar of ustekinumab, under the brand name Yesintek, was granted marketing approval by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) (1). The agent is indicated for the treatment of adults and children aged 6 and older who have moderate to severe plaque psoriasis, as well as adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.
The authorization from MHRA comes after clinical data from a trial program showed that the treatment had a comparable safety and efficacy profile to that of the originator product (1). Additional information provided by Biocon Biologics indicated that approximately 1 million people in the UK are currently living with plaque psoriasis, and 500,000 with Crohn’s (2).
Biocon Biologics’ ustekinumab biosimilar was among six biosimilars that were given positive opinions among a larger pool of 17 medicines recommended for approval, at the December 2024 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) (3). In February 2025, the European Commission (EC) followed CHMP’s recommendation and granted Biocon Biologics marketing authorization for the treatment in the European Union (EU) (4). As part of its May 25, 2025 announcement, Biocon Biologics noted that the MHRA approval is now added to the permittance of ustekinumab’s commercialization in all EU member states and the European Economic Area (1).
Information disseminated by Biocon Biologics along with that announcement shines a light on the valuable and lucrative nature of the biosimilars market. The company said that not only do biosimilars improve patient access to essential medicines, but also, along with generics, these drugs save the National Health Service—the publicly funded healthcare systems of the UK—up to £300 million (US$404 million) per year (2). Biocon Biologics has been rapidly expanding in the UK and Europe following its acquisition of Viatris’ biosimilars business, which was completed in November 2022 for more than £3 billion (now approximately US$4.04 billion) (2,5).
With regard to ustekinumab and the originator biologic Stelara—made by Janssen Biotech, a Johnson & Johnson company—the first approved biosimilar to Stelara in the European market was launched in July 2024 by STADA and Alvotech, whose biosimilar ustekinumab goes by the brand name Uzpruvo (6,7). The EC approved Uzpruvo in January 2024, making it the first ustekinumab biosimilar to be approved in Europe with equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the reference biologic.
1. Biocon Biologics. Biocon Biologics Receives MHRA Approval for Yesintek, Biosimilar Ustekinumab. Press Release. May 25, 2025.
2. Comments received via email correspondence on May 27, 2025.
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 9–12 December 2024. Press Release. Dec. 13, 2024.
4. Biocon. European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar. Press Release. Feb. 18, 2025.
5. Biocon Biologics. Biocon Biologics Completes Acquisition of Viatris’ Global Biosimilars Business. Press Release. Nov. 29, 2022.
6. Alvotech. STADA and Alvotech launch Uzpruvo, the First Approved Ustekinumab Biosimilar to Stelara, Across Europe. Press Release. July 22, 2024.
7. Mirasol, F. Biocon Biologics Scores EC Approval for Biosimilar to Ustekinumab. BioPharmInternational.com, Feb. 24, 2025.
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