Samsung Bioepis seeks Europe approval for copy of Herceptin breast cancer drug
Seoul : Bio similars maker Samsung Bioepis, part of South Korea's top conglomerate Samsung Group, said it is seeking regulatory approval in Europe to sell its copy of Roche's breast cancer drug Herceptin.
Samsung Bioepis said in a statement the European Medicines Agency (EMA) has accepted for review its application to sell its bio similar of Herceptin, a blockbuster drug that recorded 3.4 billion Swiss francs ($3.49 billion) in sales for Roche in the first half of 2016.
The firm did not say when it submitted the application for its Herceptin biosimilar, which is its first copy of a cancer drug to be submitted for regulatory approval in Europe.
The biosimilar maker is controlled by contract drug maker Samsung BioLogics, which is owned by Samsung Group's de facto holding company Samsung C&T Corp and Samsung Electronics Co Ltd.
South Korea's bourse operator last week approved Samsung BioLogics' application for an initial public offering, which analysts say could raise up to 3 trillion won ($2.72 billion).
Samsung Bioepis currently sells two bio similars of rheumatoid arthritis drugs in Europe and is also seeking EMA approval for its copy of Humira, the world's top-selling drug.