Regulatory Decision Summary for Ranopto
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.
Type of Submission:
New Drug Submission
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this new drug submission (NDS) was to seek market authorization of Ranopto (ranibizumab injection), as a biosimilar to Lucentis (ranibizumab injection), for 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); choroidal neovascularization (CNV) secondary to pathologic myopia (PM); or CNV secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous chorioretinopathy or idiopathic chorioretinopathy.
Why was the decision issued?
Ranopto contains the same active pharmaceutical ingredient, ranibizumab, as the Canadian authorized reference product Lucentis. The clinical evidence for this NDS came from a randomised, controlled, double-blinded study comparing the efficacy, safety and immunogenicity of Ranopto and Lucentis in patients with wet AMD. A total of 477 patients with wet AMD received either Ranopto (n = 238) or Lucentis (n = 239) into the studied eye via intravitreal (IVT) route every 4 weeks up to Week 48. The primary efficacy endpoint was the change from baseline in best-corrected visual acuity (BCVA) at Week 8.
The results from the clinical study demonstrated that no clinically meaningful differences in efficacy, safety, exposure and immunogenicity were observed between Ranopto and Lucentis in patients with wet AMD. Extrapolation to other sought indications, i.e., DME, RVO, PM and CNV secondary to ocular conditions other than AMD or PM, is based on adequate justifications, i.e., the same mechanism of action of ranibizumab and consistent safety profiles across the indications currently authorized for Lucentis. The proposed dose regimens of Ranopto are the same as those for Lucentis.
The final decision for this product was based on the totality of evidence, including structural, functional comparability, non-clinical data and clinical similarity in efficacy, safety, pharmacokinetics and immunogenicity between Ranopto and Lucentis.
Overall, the benefit/risk profile of Ranopto was found similar to that of Lucentis and it is therefore considered favorable for all the indications sought in adults (i.e., wet AMD, DME, RVO, PM and CNV secondary to ocular conditions other than AMD or PM).
Date of Decision:
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Drug Identification Number(s) Issued:
Available by prescription only