Samsung Bioepis has secured European approval for Opuviz, its biosimilar of aflibercept, marking its second foray into treatments for eye diseases. This approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September.
The approval allows Samsung Bioepis to broaden its ophthalmic treatment offerings, building on its existing product, Byooviz (ranibizumab). Opuviz is a biosimilar to Eylea, a drug developed by Regeneron Pharmaceuticals that addresses conditions such as neovascular age-related macular degeneration (AMD). Eylea functions by binding to vascular endothelial growth factor (VEGF), thereby inhibiting the formation of abnormal blood vessels.
Mechanism of Action and Clinical Significance
Aflibercept, the active ingredient in both Eylea and Opuviz, is a recombinant fusion protein that acts as a VEGF inhibitor. VEGF is a key mediator in angiogenesis, the formation of new blood vessels, which plays a critical role in the pathology of neovascular AMD. By inhibiting VEGF, aflibercept can reduce the growth of these abnormal blood vessels, slowing the progression of the disease and preserving vision.
Age-related macular degeneration involves the deterioration of the macula, the central part of the retina, due to aging or inflammation, leading to impaired vision and potential blindness. Neovascular AMD, also known as wet AMD, is characterized by the growth of abnormal blood vessels under the retina, which can leak fluid and blood, causing rapid vision loss. Eylea, and now Opuviz, offers a therapeutic option by targeting the underlying cause of this abnormal blood vessel growth.
Market Impact and Company Strategy
Eylea generates approximately 12 trillion won ($8.6 billion) in annual global sales, underscoring the significant market for AMD treatments. The introduction of Opuviz as a biosimilar aims to provide a more cost-effective alternative, potentially increasing access to treatment for patients with neovascular AMD.
"We are pleased to offer patients expanded treatment options," stated Jung Byoung-in, director of regulatory affairs at Samsung Bioepis. "We will continue our efforts to provide a diverse range of biopharmaceuticals."
This approval represents Samsung Bioepis’ ninth product approval in Europe, further solidifying its position in the biopharmaceutical market.
