Samsung and Biogen verge on EU approval with an Enbrel biosimilar

Samsung Bioepis CEO Christopher Hansung

Samsung Bioepis is months away from winning European clearance to market a copy of Amgen ($AMGN) and Pfizer's ($PFE) blockbuster rheumatoid arthritis treatment Enbrel, securing a positive recommendation from EU regulators.

The injection, to be marketed as Benepali, measured up to Enbrel in a 596-patient Phase III study, and the European Medicines Agency is recommending its approval as a treatment for arthritis, psoriasis and ankylosing spondylitis. The European Commission generally follows such recommendations within about three months, positioning Samsung Bioepis to launch the EU's first Enbrel biosimilar.

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

Samsung Bioepis, a joint venture with Biogen ($BIIB), is partnered up with Merck ($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 companies won their first biosimilar approval in September when South Korean regulators signed off on their version of Enbrel, marketed in that country as Brenzys.

Meanwhile, Novartis ($NVS) has come for Amgen's share of Enbrel's success, lining up for a 2016 FDA approval for its take on the antibody treatment. But the path to challenging Enbrel in the U.S. is more complicated than it is overseas. In 2011, Amgen secured new patents related to the antibody that it says will protect the treatment from biosimilar competition through 2029. Novartis has said it plans to challenge the validity of those patents and hopes to get its product on the U.S. market as soon as possible.

For its part, Amgen is working to soften the blow of coming biosimilar competition by developing copycats of its own. This year, the company is planning to submit a take on Enbrel rival Humira for FDA approval, and it has teamed up with Allergan ($AGN) on biosimilars of Eli Lilly's ($LLY) Erbitux and Roche's Avastin, Herceptin and Rituxan. On its own, Amgen is developing a version of Remicade and three more as-yet-undisclosed programs.

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