SEOUL Oct 4 Biosimilars maker Samsung Bioepis,
part of South Korea's top conglomerate Samsung Group,
said on Tuesday 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
biosimilar 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 biosimilars of
rheumatoid arthritis drugs in Europe and is also seeking EMA
approval for its copy of Humira, the world's top-selling drug.
($1 = 0.9741 Swiss francs)
($1 = 1,103.4200 won)
(Reporting by Se Young Lee; Editing by Muralikumar