Partners Merck ($MRK) and Samsung Bioepis cleared late-stage trials with their knockoff of Humira, the world's top-selling medicine, setting the stage for global regulatory applications as the reference treatment comes off patent.
The pair's injection, called SB5, met its main goal of measuring up to AbbVie's ($ABBV) blockbuster in a Phase III study on patients with rheumatoid arthritis, charting at least a 20% average improvement in symptoms after 24 weeks, Samsung Bioepis said.
The late-stage success follows last month's announcement of positive Phase III results for biosimilars of Amgen's ($AMGN) Enbrel and Johnson & Johnson's ($JNJ) Remicade, two injectable treatments that work the same way as Humira, and Samsung Bioepis and Merck have begun the regulatory process in Europe. Combined, the three TNF-blocking reference therapies grossed more than $27 billion last year.
Under a 2013 deal, the two companies are pressing forward with a pipeline of copycats targeting some of the world's best-selling biologics, including Sanofi's ($SNY) blockbuster insulin Lantus and Roche's ($RHHBY) cancer treatment Herceptin. The agreement gives Merck marketing rights to the Humira and Remicade biosimilars outside Europe, Russia and Turkey; the Enbrel copy outside the U.S., EU and Japan; and the takes on Herceptin and Lantus around the world. Samsung Bioepis plans to market the treatments on its own in the other territories.
And Merck's partner, a joint venture between Samsung and Biogen ($BIIB), is considering an IPO to raise the cash it will need to launch those treatments around the world. The company has disclosed only that it is weighing a listing on the Nasdaq and looking to raise about $1.3 billion, via IPO or otherwise, to transition into a commercial entity.
Meanwhile, the long-expected arrival of copycat biologic blockbusters is rapidly becoming a reality, as Novartis ($NVS) won FDA approval for a version of Amgen's blockbuster Neupogen in March, a milestone expected to help copycat biologics bring in more than $35 billion by 2020 as more and more treatments lose patent protection, analysts say.
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