Samsung and Biogen win first EU approval for an Enbrel copycat

Samsung Bioepis CEO Christopher Hansung Ko

A joint venture between Biogen ($BIIB) and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen ($AMGN) and Pfizer's ($PFE) blockbuster Enbrel, planning to launch its injection in the coming weeks.

The two companies, doing business as Samsung Bioepis, convinced European regulators to clear their Benepali for all of Enbrel's approved indications, including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and plaque psoriasis. In a Phase III trial on 596 patients, Benepali stacked up to Enbrel in reducing symptoms of rheumatoid arthritis, Samsung Bioepis said, also charting a comparable safety profile.

Enbrel, invented by Amgen but licensed to Pfizer outside the U.S., brought in about $2.5 billion in Europe in 2014. Johnson & Johnson's ($JNJ) Remicade, which has the same biological target as Enbrel, began facing biosimilar competition on the continent last year with the launch of a knockoff treatment from Hospira and Celltrion.

As for Amgen, the Big Biotech believes its hold on Enbrel's U.S. rights will keep it safe from a biosimilar challenge in the coming years. In 2011, Amgen secured new patents related to the antibody that the company says will protect the treatment from competition through 2029. Novartis ($NVS), leading the charge among Enbrel biosimilars developers in the U.S., is hoping to win approval for its version of the treatment this year while mounting a legal challenge on those patents.

Samsung Bioepis, formed in 2011, is partnered up with Merck ($MRK) in its biosimilar program, developing copies of Remicade, AbbVie's ($ABBV) Humira and Roche's ($RHHBY) Herceptin. Under the pair's 2013 agreement, Merck has co-marketing rights to each, including Benepali, in certain territories around the world. The American drugmaker can profit from 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.

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