South Korean biosimilar developer Samsung Bioepis has filed a lawsuit against the original maker of the world’s top-selling rheumatoid arthritis drug Humira (adalimumab), to make way for the market debut of its Humira biosimilar.
The Samsung Group affiliate and its partner and minority shareholder Biogen filed a suit in the U.K. on Mar. 24 challenging a number of patents held by U.S. pharmaceuticals giant AbbVie on Humira. It is the U.S. firm’s top-valued drug, having generated sales of $14 billion last year.
The action marks Samsung Bioepis’ first lawsuit against an original drug maker and its moves to delay the onset of biosimilar competition.
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A Samsung Bioepis employee (Samsung Bioepis) |
Biosimilars refer to cheaper, near-replicas of complex, biologic drugs which have lost patent protection. Unlike conventional chemical drugs, biologics are based on living cells and proteins, making them more difficult to make as well as impossible to replicate perfectly.
The IMS Institute for Healthcare Informatics predicts biosimilars will save as much as $110 billion for health systems in Europe and the U.S. by 2020.
Samsung Group holds high hopes for its biosimilars business led by Bioepis. The electronic giant sees biosimilars as a promising field to lead the conglomerate’s future growth.
Bioepis is aiming for a target revenue of 1 trillion won ($872 million) by 2020, which hinges on the successful commercialization of its biosimilars in the U.S. and Europe, the world’s top two biopharmaceuticals markets.
AbbVie’s formulation patent on Humira is set to expire in the U.S. in December 2016 and in Europe in October 2018, opening the doors to biosimilars whose sales would undercut profits for the original drug makers.
Seeking to defend its market share, AbbVie has been filing new patents aimed at delaying the entry of biosimilars that reference Humira, which accounted for about 61 percent of AbbVie’s net revenue in 2015.
Samsung Bioepis and Biogen have asked the U.K. High Court of Justice to nullify a number of Abbvie’s overlapping patents associated with Humira, which it perceives as invalid and an abuse of the patent system.
“We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication,” Samsung Bioepis spokesperson Mingi Hyun told The Korea Herald.
“We believe competition should take place in the market, and not through such misuse of the patent system,” he said.
AbbVie was quoted as telling Reuters that it is aware of the lawsuit filed by Samsung Bioepis and that it “intends to defend (its) intellectual property.”
Some dozen other companies, including Japan-based Fujifilm Kyowa Biologics, Coherus Biosciences and Boehringer Ingleheim have filed similar suits challenging the validity of AbbVie’s innovator patents in Europe and the U.S.
“By nature, the biosimilars business involves lots of patent lawsuits between original drug makers and biosimilar developers. Likewise, Samsung Bioepis will likely be continuously involved in patent lawsuits in the future,” said Lee Chan-hui, a biotech analyst from Hana Financial Investment.
Established in 2012, Samsung Bioepis is working on a pipeline of 13 biosimilar candidates. Its Enbrel (etanercept) biosimilar began sales in Korea last year, and is sold in U.K., Norway and Germany as well. Last Friday, its Remicade (infliximab) biosimilar received a positive approval recommendation from the European Medicines Agency.
By Sohn Ji-young (
jys@heraldcorp.com)
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