- Samsung Bioepis has applied for European approval of a biosimilar version of AbbVie's top-selling inflammatory disease drug Humira, the Korean drugmaker said on Monday. Bioepis' application is the second Humira biosimilar submitted for review in European and U.S. markets, following Amgen's lead in the U.S.
- If approved, Bioepis' candidate would be the young company's third anti-TNF alpha biosimilar in Europe. Bioepis already markets the drugs Benepali and Flixabi in the European Union, biosimilars of Enbrel and Remicade, respectively.
- Humira is AbbVie's top-selling drug, raking in $14 billion in worldwide sales last year. But its market exclusivity is under threat. In addition to Bioepis' copy, Amgen recently won the endorsement of a key advisory panel to the Food and Drug Administration for its copy of Humira.
A joint venture between Samsung BioLogics and Biogen, Samsung Bioepis has only been around for four years. But it has been aggressive in developing an extensive biosimilar pipeline, matching the efforts of Novartis, Amgen and Pfizer in the growing market for the copycat drugs. In addition to biosimilar versions of Remicade, Enbrel and Humira, Bioepis is also developing copies of Roche's drugs Avastin and Herceptin.
While Bioepis handles all research and development for its biosimilar drugs, it has partnered with both Biogen and Merck for commercialization. Biogen markets Benepali and Fliaxbi in Europe, while Merck markets both drugs under different names in Korea.
And with this most recent application to the European Medicines Agency, Bioepis became the first company to create and submit switching data for a biosimilar of Humira. The drug, known as SB5, was compared to Humira through a 52-week Phase 3 trial, which included a three-arm randomized switching study. After 24 weeks, one group of patients was switched from Humira to SB5, another continued treatment with SB5, and a third continued to receive Humira. Efficacy, safety, and immunogenicity were all comparable between the three groups after week 52.
"If approved, SB5 will join Benepali and Fixabi in Europe, which have already started to increase access to high-quality treatment options while driving down healthcare spending," said Christopher Hansung Ko, CEO of Samsung Bioepis.
With another biosimilar candidate vying for Humira market share, the threat to AbbVie's mainstay drug deepens. AbbVie's composition of matter patent expires in December of this year in the U.S., while it will remain in effect through October 2018 in most E.U. countries, according to regulatory filings. AbbVie has maintained it can protect Humira from competition through 2022, when its other related patents on the drug expire.
Last year Humira accounted for 61% of AbbVie's total revenues.