Byooviz, a Samsung Bioepis biosimilar, approved in the EU
Byooviz, a Samsung Bioepis biosimilar referencing ophthalmology treatment Lucentis, was approved for sale in the EU, the company said Monday.
The drug is an identical copy of ranibizumab, better known as Lucentis, developed by California-based Genentech. Lucentis is used to treat serious eye conditions such as age-related macular degeneration, macular edema and diabetic retinopathy. It is used to help prevent decreased vision and blindness.
With the nod from the European Commission, Byooviz has become the first biosimilar referencing Lucentis that will be sold in European countries, according to Samsung Bioepis.
Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.
The Lucentis patent expired in June 2020 in the United States and will expire in July 2022 for most parts of Europe. Last year alone, Lucentis generated revenue of around 4 trillion won globally.
“We are pleased to be the first to receive approval for a Lucentis biosimilar,” said a spokesperson for Samsung Bioepis. “We will continue our endeavors to expand our product portfolios in various treatment sectors for patients all over the world.”
Samsung Bioepis currently owns a total of 10 biosimilar products and candidates. Among them, five are currently sold in Europe.
BY SARAH CHEA [firstname.lastname@example.org]