Ilia Biosimilar ‘Ofubiz’ Approved in Europe Imminent
Product approval is usually granted within 2 to 3 months after CHMP approval recommendation
The second ophthalmic treatment following Biobiz
Approval of products and domestic sales in the US ahead of Europe
Samsung Bioepis announced on the 22nd that it had received a positive opinion (recommendation) for product approval for the ophthalmic disease treatment Ilia biosimilar ‘Ofubiz (development name SB15, active ingredient aflibercept)’ from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).
Typically, the CHMP opinion has a decisive influence on the European Commission (EC) in deciding whether to grant marketing authorization for a drug. Usually, the EC announces whether to grant marketing authorization 2-3 months after the positive opinion for marketing authorization is issued.
Aylea, the original product of Ophubiz, is a medicine developed by Regeneron in the United States. It is used to treat eye diseases such as wet age-related macular degeneration. It has a mechanism of inhibiting the formation of new blood vessels by binding to vascular endothelial growth factor (VEGF). Annual global sales are approximately 12 trillion won.
Macular degeneration is a disease that causes vision impairment due to aging and inflammation of the macula, the central nerve tissue of the retina. In severe cases, it can lead to blindness. The number of patients is increasing due to the aging population. Continuous treatment is necessary to slow the progression of macular degeneration.
Samsung Bioepis currently has a total of eight biosimilar products launched in the European market. If Opubiz receives official approval, it will complete its product lineup of nine products. In addition, it is expected to strengthen its market influence by expanding its portfolio of ophthalmic treatment drugs following the existing Bioubiz (Lucentis biosimilar, SB11, active ingredient ranibizumab).
Jeong Byeong-in, executive director and head of the regulatory affairs (RA) team at Samsung Bioepis, said, “We will continue to do our best to provide patients with a variety of treatment options by securing diverse pipelines.”
Meanwhile, Samsung Bioepis obtained product approval for Opiviz in the United States in May. In Korea, it is being sold under the product name ‘Apilibu’ through a partnership with Samil Pharmaceutical.
Kim Min-beom, Donga.com reporter [email protected]
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2024-09-22 15:41:34