On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic plaque psoriasis (PsO). The study reportedly demonstrated equivalent efficacy, safety, immunogenicity and pharmacokinetics between the biosimilar and its reference product and continued efficacy and safety of switching from Stelara® to Yesintek™ from week 16 to week 52. Biocon intends to present the results at the March 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.
Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for adult patients with moderate to severe PsO who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.
The European Commission granted marketing authorisation for Yesintek™ in February 2025 for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease. The European approval followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.