Biocon Biologics Ltd, a global leader in biosimilars, recently achieved a significant milestone. On October 17, Health Canada approved Yesintek™ (ustekinumab injection) and Yesintek™ I.V. This is a biosimilar to Stelara®, used for treating various autoimmune conditions. It’s set to be available in Canada by mid-October.
Yesintek will help those facing challenges like moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Thousands of Canadians struggle with these conditions, making this approval crucial.
This decision came after a thorough review, confirming that Yesintek is very similar to Stelara, showing no important differences in effectiveness, safety, or immunogenicity. Patients can access Yesintek through the My Biocon Biologics™ support program. The drug is available in various forms: a subcutaneous injection (45 mg and 90 mg) and an intravenous solution (130 mg/26 mL).
Shreehas Tambe, CEO of Biocon Biologics, shared his enthusiasm: “This approval supports our goal of providing affordable healthcare options to patients with chronic autoimmune diseases.” He emphasized the company’s commitment to expanding its presence in North America following a successful launch in the U.S.
Ramy Ayad, Biocon’s Head of Canada, echoed this sentiment, stating that Yesintek provides a trusted and cost-effective treatment option. By increasing access to biosimilars, the company aims to improve patient outcomes and foster a sustainable healthcare system in Canada.
According to a recent report from the Canadian Institute for Health Information (CIHI), the use of biosimilars could potentially save the Canadian healthcare system over $2.5 billion by 2025. This factor makes Yesintek not just a new treatment but a step towards more affordable healthcare for many.
The Phase 3 STELLAR-2 study indicated no significant differences between Yesintek and Stelara in pharmacokinetics, safety, or efficacy. This reinforces the trust in biosimilars as effective alternatives to more expensive biologics.
However, as with any medication, caution is advised. Potential side effects include an increased risk of infections and malignancies. Patients should consult healthcare professionals before starting treatment, especially those with histories of severe infections or malignancies.
Biocon Biologics isn’t just addressing patient needs—they’re leading a change in the healthcare landscape. Their innovations have already transformed lives across 120 countries, impacting over 6 million patients. With a pipeline of twenty biosimilars targeting serious conditions, they continue to expand access to effective treatments.
In sum, the approval of Yesintek is a leap forward for many Canadians in need of effective and affordable treatment options. Biocon Biologics remains committed to transforming healthcare and improving lives through innovative solutions.
