Merck’s biosimilar to AbbVie’s Humira wins FDA approval

(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 Mylan NV and Biogen Inc.