Samsung, Biogen Reach Deal With AbbVie to Sell Near Copy of Humira
Samsung Bioepis Co. said Thursday it has reached a settlement with AbbVie Inc. ABBV -1.04% that will allow it to market a near-replica version of one of the world’s top-selling drugs Humira.
Under the terms of the agreement, AbbVie will grant Samsung and its partner Biogen Inc. BIIB -2.53% a nonexclusive license that allows the companies to sell their biosimilar version of the rheumatoid-arthritis treatment under the name Imraldi. AbbVie will also collect royalties from the companies once the product is launched.
Biogen, which will handle the marketing of Imraldi in Europe, can begin selling the product in Europe as early as October, according to the agreement.
The license allows South-Korea-based Samsung to begin selling the product in the U.S., upon gaining regulatory approval, starting June 30, 2023.
Another U.S. company, Amgen Inc., AMGN -1.29% will launch its own version of Humira in January of 2023. Amgen and AbbVie settled a patent dispute over Humira last year.
Last year Imraldi became the third Samsung-developed medication to win government approval in Europe or the U.S. All three treatments are close imitations of rheumatoid-arthritis drugs that rank among the world’s biggest sellers. Samsung’s version of Johnson & Johnson’s Remicade won U.S. Food and Drug Administration approval to begin sales last year. In Europe, Samsung has sold the Remicade near-replica and its version of Pfizer Inc.’s Enbrel since 2016.
Samsung and other new players have been working to produce lower-priced near-replicas of biologic drugs, akin to the generic versions of chemically synthesized drugs like aspirin, but rake in tens of thousands of dollars per annual treatment. Efforts to sell or block these so-called biosimilar treatments have led to a flood of lawsuits in the U.S. and Europe.
The agreement announced Thursday suspends any pending litigation, the companies said.
Write to Imani Moise at imani.moise@wsj.com