Samsung Bioepis Cleared for Eye Treatment Biosimilar Sale in Europe and UK, Reaches Settlement with Regeneron and Bayer Samsung Bioepis, a global biopharmaceutical company, has recently secured clearance from the European Commission for the marketing authorization of its biosimilar, SB15, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). As a result of this approval, Samsung Bioepis will be able to market and sell SB15 throughout Europe, including the United Kingdom. The newly approved SB15 is a biosimilar to Lucentis, a leading treatment for AMD and DME developed by Genentech, a subsidiary of Roche. Biosimilars, also known as follow-on biologics, are copies of complex biologic medicines that are approved for use by health authorities after demonstrating that they have the same safety and efficacy as their reference products. Samsung Bioepis had entered into an exclusive licensing agreement for the commercialization of SB15 in Europe with Regeneron Pharmaceuticals and Bayer, which holds the rights to the branded product, Lucentis. However, due to a dispute over patent infringement and commercialization, the parties were engaged in a litigation battle. Following extensive negotiations, the two companies have now reached a settlement agreement, which clears the path for Samsung Bioepis to sell SB15 in Europe. In a statement released by the company, Samsung Bioepis expressed its satisfaction with the outcome and its commitment to addressing the unmet needs of European patients suffering from AMD and DME. "We are pleased to have reached a settlement with Regeneron and Bayer that will enable us to provide our high-quality biosimilar option to European patients," said Christopher Hansung Ko, Chief Executive Officer of Samsung Bioepis. "Our SB15 biosimilar has undergone rigorous scientific evaluation and has demonstrated excellent efficacy and safety profiles, making it an excellent option for healthcare professionals and patients alike." The European approval of SB15 is expected to have a significant impact on the European biosimilar market, which has been witnessing steady growth over the years. Several biosimilars have entered the market in Europe in recent years, offering patients more affordable treatment options for chronic diseases. The introduction of SB15 is expected to provide an additional choice for healthcare professionals and patients in the treatment of AMD and DME. As part of the settlement reached with Regeneron and Bayer, Samsung Bioepis has agreed to withdraw its marketing authorization application for SB15 in the United Kingdom. The UK approval of SB15 is expected to follow in due course, however, as part of the broader European approval. Samsung Bioepis' approval of SB15 in Europe and UK marks an important milestone in the company's expansion plans, reflecting its ability to develop, manufacture, and commercialize biosimilar products for European markets. With its commitment to delivering quality, affordable medicines to patients worldwide, Samsung Bioepis is well-positioned to continue making a meaningful impact in the global biopharmaceutical industry. The settlement agreement between Samsung Bioepis and Regeneron and Bayer underscores the growing importance of biosimilars in addressing pressing healthcare needs while driving the growth of the biopharmaceutical industry.