In the last few weeks, Health Canada issued several decisions concerning biologics.
On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and YESINTEK I.V. (ustekinumab for injection, solution for intravenous infusion). YESINTEK and YESINTEK I.V. are biosimilars to Janssen Biotech, Inc.’s STELARA and STELARA I.V. YESINTEK and YESINTEK I.V. are indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients and in certain pediatric patients, active psoriatic arthritis in adults, moderately-to-severely active Crohn’s disease, and ulcerative colitis in adults. Ustekinumab is a fully human IgG1қ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin IL-12 and IL-23 mediated signaling associated with immune-mediated diseases. According to Biocon, the approval paves the way for commercial availability of the products this month.
The same day, Health Canada also approved, via a Notice of Compliance, Apotex, Inc.’s LOQTORZI (toripalimab) for the treatment of metastatic or recurrent unresectable nasopharyngeal carcinoma. Toripalimab is a programmed death receptor-1 (PD-1) blocking antibody. According to Apotex, LOQTORZI is the first and only Health Canada-approved immune-therapy for patients with metastatic or recurrent unresectable nasopharyngeal cancer. Apotex has an exclusive agreement with Coherus Biosciences, Inc. to license Canadian rights to toripalimab.
Health Canada approved a new indication for Pfizer Canada ULC’s ABRYSVO (respiratory syncytial virus vaccine), for use in adults aged 18-59 at increased risk for lower respiratory tract disease caused by RSV. ABRYSVO is a stabilized prefusion F subunit bivalent vaccine that was previously approved for treatment of lower respiratory tract disease caused by RSV in adults over 60 and infants from birth through 6 months of age via maternal immunization.
On October 21, Health Canada approved Sanofi-Aventis Canada Inc.’s DUPIXENT (dupilumab) as an add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (“COPD”) based on certain characteristics. DUPIXENT is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 pathways. DUPIXENT was first approved in Canada in 2017 for the treatment of adults with moderate-to-severe atopic dermatitis. Since then, Health Canada has approved DUPIXENT for several additional indications. According to Sanofi, DUPIXENT is the first and only biologic approved for adults living with inadequately controlled COPD characterized by elevated blood eosinophils.
On October 24, Health Canada also approved, via a Notice of Compliance with Conditions, Eisai Co., Ltd. and Biogen Canada Inc.’s LEQEMBI (lecanemab). LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). The product is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease caused by a specific underlying condition. According to Eisai and Biogen Canada, LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease. LEQEMBI is currently approved in 51 other countries.