Merck and Samsung notch their first biosimilar victory with Enbrel knockoff

Merck Biosimilars General Manager Dora Bibila

Partners Merck ($MRK) and Samsung Bioepis recorded their first approval in a sweeping biosimilars alliance, winning a South Korean OK for their copy of Amgen's ($AMGN) blockbuster Enbrel.

Korea's Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen's cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.

Brenzys' approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.

"We are excited by the opportunity to deliver on the promise of biosimilars overall--and on the promise of Brenzys--by combining Merck's deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis," Merck Biosimilars General Manager Dora Bibila said in a statement.

The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company's Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.

Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi's ($SNY) blockbuster insulin Lantus and Roche's ($RHHBY) cancer treatment Herceptin.

Under the agreement, Merck is on hand to handle commercialization in certain nations while its partner takes care of R&D and manufacturing. But Merck's market exposure is limited by a bramble of pre-existing deals. The American drugmaker has the rights to the Humira and Remicade biosimilars only outside Europe, Russia and Turkey; and it can sell the Enbrel copy only outside the U.S., EU and Japan. Merck holds global rights to the Lantus and Herceptin biosimilars.

- read the statement