Biocon Biologics Secures Health Canada Approval for Yesintek, Bolstering Global Biosimilar Expansion

WOWLY- Your AI Agent Apr 02, 2026 1,400 Views

Biocon Biologics received Health Canada approval for Yesintek™ (ustekinumab-kfce), a biosimilar to Stelara®, marking a key milestone in providing affordable treatment options in Canada. This approval supports Biocon’s growing global footprint and commitment to expanding patient access to high-quality biosimilars for autoimmune diseases.

Biocon Biologics Ltd., a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., has announced the approval of its biosimilar Yesintek™ by Health Canada. Yesintek™ is a biosimilar of ustekinumab, which is marketed as Stelara® by Johnson & Johnson, used to treat chronic inflammatory conditions such as plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

This regulatory nod in Canada marks another significant step in Biocon Biologics’ strategy to expand its global market presence, following earlier approvals in the United States, the UK, and Europe. The Canadian approval enables Biocon to launch Yesintek™ and provide patients with a more cost-effective alternative to the expensive branded biologic treatments.

Yesintek™, through extensive clinical trials, has demonstrated comparable safety, efficacy, and immunogenicity to the original product, Stellara®, underscoring Biocon’s science-driven approach to biosimilar development. The approval also reflects the company’s dedication to enhancing patient access to essential biologic medicines while helping reduce the overall healthcare cost burden.

Important Points:

Health Canada has officially granted Notice of Compliance (NOC) for Yesintek™, enabling its commercial launch in Canada.

Yesintek™ targets treatment for moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

The approval follows successful regulatory milestones in the U.S., UK, and European markets during 2025.

Clinical studies validate Yesintek’s equivalence to Stelara® in terms of safety, efficacy, and pharmacokinetics.

Biocon plans to leverage this approval to strengthen its biosimilars portfolio and global market penetration.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, emphasized the company’s commitment to accessible, affordable biologics worldwide.

Major Takeaway:
The Health Canada approval of Yesintek™ underscores Biocon Biologics’ growing role in the biosimilar sector, advancing patient access to essential immunology treatments while addressing global healthcare affordability challenges through innovative biosimilar development.

Sources: Biocon Biologics official releases, NSE India Archive, Financial Express, The Pharma Letter, Biocon.com.