* First request for Europe approval for cancer drug copy
* Firm already selling two biosimilars in Europe
* Top shareholder Samsung BioLogics planning S.Korea IPO
(Updates with comments from Bioepis, BioLogics IPO details)
SEOUL, Oct 4 South Korea's Samsung Bioepis, a
maker of cheaper copies of complex biotech drugs known as
biosimilars, is seeking regulatory approval in Europe to sell
its copy of Swiss giant Roche's blockbuster breast
cancer drug Herceptin.
Samsung Bioepis, part of South Korea's top conglomerate
Samsung Group, said in a statement on Tuesday the
European Medicines Agency (EMA) has accepted for review its
application to sell its biosimilar of Herceptin. Roche recorded
sales of the drug totalling 3.4 billion Swiss francs ($3.49
billion) in first-half 2016.
Interest in biosimilars has soared in recent years as copies
of some of the world's best-selling medicines have hit the
market at big discounts. Bioepis said it submitted the Herceptin
biosimilar application - its first copy of a cancer drug to be
submitted for regulatory approval in Europe - in August.
As of end-June, Bioepis was 91.2 percent owned by Samsung
BioLogics, which separately on Tuesday announced plans for an
initial public offering that could raise up to 2.25 trillion won
($2 billion). BioLogics is controlled by Samsung Group's de
facto holding company Samsung C&T Corp and Samsung
Electronics Co Ltd.
U.S. biopharmaceuticals maker Biogen Inc is a
minority shareholder in Bioepis with an 8.8 percent stake as of
Bioepis, which seeks to be first or second to market with
its products, received European regulatory approval earlier this
year to sell copies of Amgen Inc's Enbrel and Johnson &
Johnson's Remicade - two blockbuster rheumatoid
It is also seeking European approval for its biosimilar of
arthritis treatment Humira, the world's top-selling drug.
($1 = 0.9741 Swiss francs)
($1 = 1,103.3300 won)
(Reporting by Se Young Lee; Editing by Muralikumar Anantharaman
and Kenneth Maxwell)