Health Canada Approves Omlyclo Advancing Allergy and Respiratory Care

Omlyclo is the first omalizumab biosimilar that Health Canada has approved exclusively for use in Canada. It is indicated for allergic and respiratory conditions like chronic idiopathic urticaria (CIU), allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). The new biosimilar is the same as the reference product, Xolair, concerning both efficacy and safety and will be available in two dosage forms for subcutaneous injection. It has been confirmed in a global Phase III study for therapeutic equivalence. This will do a lot to advance the biosimilar landscape in Canada, providing one much-needed option from a small pool of anti-IgE therapies available.

Broadening Access to Biologic Medicines

Health Canada approved Omlyclo™ for chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps in a neater manner. This would have significant implications for U.S. healthcare. Moreover, as a biosimilar reference to Xolair® (omalizumab), it comes in subcutaneous injections with two strengths. The success of Omlyclo™ has made a base for the widespread introduction of biosimilars throughout North America, decreasing prices while remaining clinically efficacious, thus relieving healthcare systems from costly burdens in patient care.

Clinical Evidence Supports Efficacy

The newly approved biologic, Omlyclo™, was granted approval after a global Phase III clinical trial conducted in comparison to Xolair® which demonstrated that both of them are therapeutically equivalent. The equivalence fills a gap in the unmet need of patients with CIU and other allergic conditions, as it provides affordably accessible options without compromising quality care in one critical unmet need.

Expert Perspectives

Canada’s primary patient omalizumab biosimilar is known as Omlyclo™. It has been approved by Dr. Elena Netchiporouk, assistant professor of dermatology at MUHC, as the first anti-IgE antibody for chronic inflammatory bowel disease as well as asthma. With this approval, patients can now expect wider access and affordability in treatments for these conditions, hence improving their lives. The Managing Director of Celltrion Healthcare Canada, Jungyong Shin, also pointed out the Company’s commitment to innovation and affordability; she added that the approval is a further commitment to providing high-quality biologic medicines at lower prices.

Celltrion’s Expanding Biosimilar Portfolio

• Remsima™ SC (infliximab)
• Yuflyma® (adalimumab)
• Vegzelma® (bevacizumab)
• SteQeyma® (ustekinumab)
•  Omlyclo™ (omalizumab)

These approvals reflect Celltrion’s commitment to advancing healthcare solutions that balance cost efficiency and therapeutic innovation.

Impact on North American Healthcare

The approval of Omlyclo™ in Canada is a milestone both for Celltrion and the entire healthcare industry as it now offers a less costly alternative to Xolair®, thus minimizing healthcare expenses and strengthening the biosimilar marketplace. The resulting success of Omlyclo™ in Canada can then be expanded to North America and ultimately widen access and improve patient outcomes for allergic and respiratory diseases. This milestone also adds momentum to biosimilars in bridging the treatment gaps in chronic diseases and encourages future innovations in biologics.