Biocon has announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Yesintek® (ustekinumab-kfce) as a single-dose prefilled autoinjector. Yesintek® is a biosimilar to Stelara® (ustekinumab), a biologic therapy used across several immune-mediated inflammatory diseases. The approval represents another advancement in Biocon’s expanding biosimilar portfolio and strengthens its presence in the U.S. immunology market.
Ustekinumab is a fully human monoclonal antibody that selectively targets interleukin-12 (IL-12) and interleukin-23 (IL-23), cytokines involved in inflammatory and immune-mediated pathways. By binding to the p40 subunit shared by IL-12 and IL-23, ustekinumab inhibits their interaction with the IL-12Rβ1 receptor and modulates downstream inflammatory signaling. The U.S. FDA approval of Yesintek® covers the approved indications for ustekinumab, including moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients meeting the applicable criteria. It is also approved for adults with moderately to severely active Crohn’s disease and ulcerative colitis.
A key feature of this approval is the single-dose prefilled autoinjector presentation. The device is designed to support subcutaneous administration and may offer a convenient option for patients requiring maintenance treatment outside of a healthcare setting, where self-administration is appropriate. The approval adds to Biocon’s growing portfolio of complex biologics and biosimilars, reflecting the company’s focus on expanding access to high-quality biologic therapies. Biosimilars can contribute to greater treatment accessibility by introducing additional treatment options and supporting competition within the biologics market.
Yesintek® therefore represents a significant addition to Biocon’s U.S. portfolio, combining an established mechanism of action with a patient-friendly delivery presentation. The availability of a single-dose prefilled autoinjector may further support treatment convenience for eligible patients managing chronic inflammatory diseases. Overall, the U.S. FDA approval of Yesintek® highlights Biocon’s continued progress in biosimilars and immunology. It also reinforces the company’s strategy of developing and commercializing complex biologic products aimed at broadening access to therapies for patients with chronic immune-mediated conditions.
