Biocon Biologics Receives Health Canada Approval for Ustekinumab Biosimilar Yesintek
核心洞察
Health Canada granted Notice of Compliance for Yesintek, Biocon Biologics (搜索)' ustekinumab biosimilar to Stelara, on October 17, 2025, enabling commercial launch in mid-October.
The approval covers treatment of moderate to severe plaque psoriasis (搜索), active psoriatic arthritis (搜索), and moderately to severely active Crohn's disease (搜索) and ulcerative colitis (搜索) in specified patient populations.
Yesintek demonstrated high similarity to reference biologic Stelara with no clinically meaningful differences in efficacy, safety, or immunogenicity based on comprehensive data package.
Biocon Biologics (搜索) Ltd has received Health Canada approval for Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection, solution for intravenous infusion), marking a significant expansion of the company's biosimilar portfolio in North America. The Notice of Compliance (NOC) was granted on October 17, 2025, clearing the path for commercial availability in Canada by mid-October.
Approved Indications and Patient Populations
Health Canada's approval encompasses treatment for moderate to severe plaque psoriasis (搜索) in adult patients and pediatric patients aged 6-17 years, active psoriatic arthritis (搜索) in adults, and moderately to severely active Crohn's disease (搜索) and ulcerative colitis (搜索) in adults. These autoimmune conditions affect thousands of Canadians and represent significant unmet medical needs in the healthcare system.
Clinical Evidence and Regulatory Basis
The regulatory approval was supported by a comprehensive data package demonstrating that Yesintek is highly similar to the reference biologic Stelara with no clinically meaningful differences in efficacy, safety, and immunogenicity. The Phase 3 STELLAR-2 study specifically demonstrated no clinically meaningful differences between Yesintek and Stelara in terms of pharmacokinetics, efficacy, safety, and immunogenicity.
Yesintek is a fully human IgG1κ monoclonal antibody that functions as a first-in-class agent, binding with specificity to the shared p40 protein subunit (搜索) of human cytokines interleukin IL-12 (搜索) and IL-23 (搜索), which mediate signaling associated with immune-mediated diseases.
Product Formulations and Availability
The biosimilar will be available in multiple formulations to accommodate different treatment needs:
Subcutaneous injection options:
- 45 mg/0.5 mL (available in both prefilled syringe and vial)
- 90 mg/mL (prefilled syringe)
Intravenous infusion:
- Yesintek I.V.: 130 mg/26 mL (5 mg/mL)
Patients will have access to Yesintek through the My Biocon Biologics (搜索) patient support program, which provides assistance to individuals prescribed with the therapy.
Safety Profile and Precautions
The approved product carries important safety considerations consistent with ustekinumab therapy. Key contraindications include hypersensitivity to the drug or its components and severe infections such as sepsis, tuberculosis, and opportunistic infections.
Critical warnings and precautions encompass infection risk management, with requirements for tuberculosis evaluation prior to treatment initiation and ongoing monitoring for signs and symptoms of infection. The therapy may increase malignancy risk, particularly requiring skin cancer monitoring in patients over 60 years of age, those with prolonged immunosuppressant therapy history, or prior PUVA treatment.
Additional precautions include careful consideration of concomitant immunosuppressive therapy, restrictions on live viral or bacterial vaccines during treatment, and specific guidance for women of childbearing potential to use effective contraception during treatment and for at least 15 weeks after the last dose.
Market Impact and Company Perspective
"Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars," said Shreehas Tambe, CEO & Managing Director of Biocon Biologics (搜索). "Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions."
Ramy Ayad, Head of Canada at Biocon Biologics (搜索), emphasized the company's commitment to advancing biosimilar adoption in Canada: "We are excited to bring Yesintek to Canadian patients, providing a trusted, value-driven ustekinumab biosimilar. Biocon Biologics is committed to advancing biosimilar adoption in Canada to improve outcomes for patients and deliver meaningful savings to the healthcare ecosystem."
Strategic Significance
This approval represents another milestone in Biocon Biologics (搜索)' global mission to make advanced biologic therapies more accessible and affordable. The company has commercialized 10 biosimilars from its portfolio, serving over 6.0 million patients across 120+ countries, with a pipeline of 20 biosimilar assets across multiple therapeutic areas including diabetology, oncology, immunology, ophthalmology, and bone health.