BENGALURU, Karnataka, India, July 29, 2026
Biocon Limited has announced that its Canadian subsidiary has received Health Canada Notice of Compliance (NOC) approval for the Yesintek® (ustekinumab) Autoinjector Pen in 45 mg/0.5 mL and 90 mg/mL presentations, expanding treatment options for patients living with chronic autoimmune diseases. The approval follows Health Canada’s earlier authorization of Yesintek® prefilled syringes, vials, and intravenous infusion formulations in October 2025 and represents another important milestone in Biocon’s global biosimilars strategy. The newly approved autoinjector provides Canadian patients with a self-administration option that is not currently available with the originator product, offering greater convenience, flexibility, and individualized treatment across multiple care settings. The approval strengthens Biocon’s growing immunology portfolio while reinforcing its commitment to improving access to high-quality, affordable biologic medicines for patients worldwide suffering from chronic inflammatory disorders.
Health Canada Expands Access to Yesintek® Treatment Options
The Health Canada Notice of Compliance for the Yesintek® Autoinjector Pen broadens the availability of Biocon’s ustekinumab biosimilar by introducing a user-friendly delivery system that enables patients to administer therapy more conveniently. The autoinjector has been approved in both 45 mg/0.5 mL and 90 mg/mL strengths, complementing the previously approved prefilled syringe, vial, and intravenous infusion formulations. Unlike the reference product currently marketed in Canada, the availability of an autoinjector offers patients and healthcare providers an additional administration choice that may improve treatment convenience and support individualized care decisions. By expanding formulation options, Biocon continues to address evolving patient preferences while enhancing flexibility for physicians managing long-term biologic therapy across hospital, clinic, and home-care environments.
Supporting Patients with Multiple Autoimmune Diseases
Yesintek® (ustekinumab) is indicated for the treatment of several chronic immune-mediated inflammatory diseases, including moderate-to-severe plaque psoriasis in adults and pediatric patients aged 6 to 17 years, active psoriatic arthritis in adults, moderately to severely active Crohn’s disease, and ulcerative colitis in adults. These chronic autoimmune disorders often require long-term biologic treatment to reduce inflammation, improve quality of life, and prevent disease progression. The introduction of the autoinjector pen provides an additional administration option that may simplify ongoing therapy for eligible patients while supporting treatment adherence through convenient self-administration. As biologic therapies continue to transform the management of autoimmune diseases, expanding patient access to multiple delivery formats remains an important component of comprehensive chronic disease care.
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Biocon Strengthens Global Biosimilars Leadership
The latest Health Canada approval further reinforces Biocon’s leadership in biosimilars and immunology, expanding the company’s international portfolio of advanced biologic medicines. As healthcare systems increasingly focus on improving patient access while controlling treatment costs, biosimilars continue to play an important role in expanding the availability of high-quality therapies for complex chronic diseases. By offering an autoinjector format unavailable with the originator product in Canada, Biocon demonstrates its commitment to innovation beyond biosimilarity by enhancing patient convenience and treatment flexibility. The approval also reflects the company’s ongoing strategy to broaden global access to affordable biologics through regulatory excellence and continued investment in advanced drug delivery technologies. With demand for biologic therapies continuing to grow worldwide, Biocon remains focused on delivering innovative, accessible treatment options that improve patient outcomes across immunology and other therapeutic areas.
Source: Biocon press release
