Samsung Bioepis wins South Korea nod for SB4, etanercept biosimilar

Samsung Bioepis CEO Christopher Hansung

Samsung Bioepis has received South Korean approval for a biosimilar of rheumatoid arthritis drug etanercept, dubbed Brenzys, marking a first with a launch slated by the end of 2015 or early next year with commercial operations in partnership with Merck Sharp & Dohme ($MRK).

The joint venture between Samsung Group and Biogen ($BIIB) is on track to make biosimilars of some of the world's best-selling drugs and aims to raise as much as $1 billion in a U.S. initial public offering likely next year to further its plans.

In three years, Samsung Bioepis has worked on biosimilars at the end of patent periods worldwide and has spread its efforts into marketing agreements to reach Europe and the U.S. for a market poised to cross $35 billion in annual sales in the next 5 years.

Among the other biosimilars in advanced clinical stages or that have either received or await regulatory approvals are Amgen's ($AMGN) Enbrel, Johnson & Johnson's ($JNJ) Remicade, Roche's ($RHHBY) Herceptin and AbbVie's ($ABBV) Humira. The company also has a Phase I clinical trial for as biosimilar of Avastin, according to its website and is in the late stage of a Phase III global clinical study for SB9, its biosimilar version of Sanofi's ($SNY) blockbuster Lantus, with a filing planned in the U.S. in the latter half of this year and in Europe early next year.

"The approval of Brenzys demonstrates Samsung Bioepis' ability to develop biosimilars in accordance with stringent regulatory pathways and with shorter development timelines than others," Christopher Hansung, CEO of Samsung Bioepis, said in a release.

"With this first approval, and an extensive biosimilars development pipeline, we look forward to continuing to provide value-creating solutions for patients globally."

The Samsung Bioepis manufacturing arm aims to sharply raise production capacity and become the world's top contract manufacturing organization by 2020, the Korea Economic Daily had previously reported, noting the capacity would, in part, help Samsung Bioepis meet production targets.

Earlier reports said the company could be valued at least $7 billion after listing its shares.

- here's the release