Score one for Samsung Bioepis in its quest to bring a biosimilar version of AbbVie’s anti-inflammatory behemoth Humira to market in Europe.
This week, a U.K. court upturned two of the med’s European patents, determining that AbbVie’s rheumatoid arthritis (RA), psoriasis and psoriatic arthritis indications for the drug couldn’t be patent-protected, CNBC reports.
It’s a blow for the Illinois drugmaker, which has pledged to “vigorously” defend its intellectual property on Humira, the world’s best-selling drug, which brought in a whopping $16 billion in 2016 sales. AbbVie relies heavily on the product for top-line growth, and it’s expecting Humira to post sales increases in the mid- to high teens this year.
And this isn't the first legal hit on AbbVie's Humira patents. Last May, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board announced it would review Coherus Biosciences' challenge to Humira’s ‘135 method patent. It covers Humira’s RA dosing regimen and “constitutes one of the cornerstones of the Humira IP estate,” Barclays analysts wrote at the time.
Plus, the AbbVie blockbuster already has an FDA-approved stateside challenger in Amgen’s Amjevita, which won its regulatory green light last September. The Big Biotech is holding off on an at-risk launch for now; CEO Robert Bradway has said the copycat won’t hit the U.S. scene until next November.
Meanwhile, the U.K. ruling is a victory for Samsung Bioepis, a biosimilars joint venture between Samsung Biologics and Biogen. The Humira knockoff, for now dubbed SB5, is one of four late-stage products in the team's pipeline, along with versions of Roche cancer stars Avastin and Herceptin and Sanofi’s behemoth insulin Lantus. Samsung already has European go-aheads for its biosimilars of Enbrel and Remicade, big-time anti-inflammatory sellers that are marketed on the continent by Pfizer and Merck, respectively.