(Health Korea News / Yu Ji-in) The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) announced on the 20th (local time) that it had a positive opinion on Samsung Bioepis’ Iylea biosimilar ‘Opuviz (active ingredient: aflibercept)’ for product approval. Accordingly, the European Commission (EC) is expected to decide whether to approve product approval within 2-3 months.
The positive CHMP opinion was based on the totality of evidence, including analytical, nonclinical and clinical data. The phase 3 study (project name SB15) demonstrated equivalent efficacy and similar safety, immunogenicity and pharmacokinetic (PK) profiles between Opiviz and Eylea. The primary endpoint was met in terms of change from baseline in best-corrected visual acuity (BCVA) at week 8. The 32-week interim analysis and the 56-week analysis demonstrated equivalence between Opiviz and Eylea in other secondary efficacy, safety, immunogenicity and PK endpoints.
If approved by the EC, Opiviz will be the second ophthalmic biosimilar to be approved in Europe. For Samsung Bioepis, this will be the fifth biosimilar to be approved, following Byoviz (ranibizumab), Benepali (etanercept), Imraldi (adalimumab), and Flixabi (infliximab).
Aylea, the original drug of Opiviz, is a treatment for eye diseases such as wet age-related macular degeneration developed by Regeneron in the United States. Its mechanism is to bind to vascular endothelial growth factor and inhibit the formation of new blood vessels.
Age-related macular degeneration is a disease in which the macula (the center of the retina) is attacked and damaged by oxygen radicals due to exposure to harmful environments such as environmental pollution and excessive exposure to light, and a lack of antioxidant function as a result of age. If it becomes severe, it can lead to blindness.
Samsung Bioepis became the first company to obtain approval for Ophubiz, a similar drug to IliaBio, in the United States in May, and has been selling it in Korea since May under the product name ‘Apilibu’ through its partner company, Samil Pharmaceutical.
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