Samsung Biologics, Biogen Venture Gets FDA OK for Humira Biosimilar

By Colin Kellaher

Samsung Bioepis Co. on Wednesday said the U.S. Food and Drug Administration approved Hadlima, a biosimilar of AbbVie Inc.'s (ABBV) blockbuster drug Humira, for several inflammatory conditions.

Samsung Bioepis, a joint venture between Korea's Samsung BioLogics Co. (207940.SE) and Biogen Inc. (BIIB) of the U.S., said the approval covers the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Biosimilars are near-copies of biologic drugs, such as Humira, that are made from living cells and are analogous to generic copies of traditional pill-form medicines.

Humira, the world's biggest-selling drug, had nearly $20 billion in global sales in 2018, accounting for about 61% of AbbVie's total revenue.

Sales of Humira biosimilars began in Europe late last year after a key AbbVie European patent expired, but a group of U.S. patents built up by AbbVie has prevented a U.S. launch.

Samsung Bioepis said Hadlima will launch in the U.S. after June 30, 2023, under a licensing agreement with AbbVie, adding that Merck & Co. (MRK) will commercialize the drug in the U.S.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

July 24, 2019 11:14 ET (15:14 GMT)

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