(Reuters) – The U.S. Food and Drug Administration approved Merck & Co Inc’s biosimilar to AbbVie Inc’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday.
The drug, Hadlima, is manufactured by Samsung Bioepis Co Ltd for Merck and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis and bacterial sepsis. (bit.ly/30QH1M3)
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.
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…
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