Regulatory Decision Summary for Byooviz (ranibizumab)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this new drug submission (NDS) was to seek market authorization of the biosimilar biologic drug, Byooviz (ranibizumab), for use in the treatment of Neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), or choroidal neovascularization (CNV) secondary to pathologic myopia (PM) or ocular conditions other than AMD or PM, including but not limited to angioid streaks, postinflammatory retinochoroidopathy, central serous chorioretinopathy or idiopathic chorioretinopathy.
Why was the decision issued?
Byooviz contains the same active pharmaceutical ingredient ranibizumab as the Canadian authorized reference product Lucentis. The results from the clinical comparative study demonstrated that no clinically meaningful differences in efficacy, safety, and immunogenicity were observed between Byooviz and Lucentis in patients with AMD. Extrapolation to other sought indications, i.e., visual impairment due to DME, RVO, or CVN, is based on adequate justifications, i.e. the same mechanism of action of ranibizumab and the findings of consistent safety profiles across the indications currently approved for Lucentis.
The final decision for this product was based on the totality of evidence, including structural, functional comparability and clinical similarity in efficacy, safety, and immunogenicity between Byooviz and Lucentis.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations