The drug, Hadlima, was developed by South Korea's Samsung Bioepis
and comes with a boxed warning, the FDA's harshest. The agency
flagged increased risk of serious infections, including tuberculosis
and bacterial sepsis. (https://bit.ly/30QH1M3)
Merck & Co Inc will commercialize the treatment in the United
States.
Humira also comes with a black box warning, according to the FDA.
In October, the FDA approved Novartis AG's copy of Humira. Humira
already faces competition from biosimilars in Europe.
[to top of second column] |
Humira is the world's best-selling prescription medicine and in the
six years since AbbVie spun out from device maker Abbott Labs, the
drug has remained by far its top-earner. It brought in revenue of
$19.94 billion for AbbVie in 2018.
AbbVie in November lowered its forecast for overseas sales of Humira,
citing stiff competition in Europe from drugmakers including Mylan
NV and Biogen Inc.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Bernard
Orr)
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