FDA approves Celltrion's biosimilar to Roche's Herceptin

The U.S. Food and Drug Administration on Friday approved South Korean drugmaker Celltrion Inc's biosimilar to Roche Holding AG's blockbuster breast cancer treatment, Herceptin.

The treatment, which generated sales of about $7.18 billion in 2017, has been a main contributor to Roche's profits and is one of the world's most successful antibody drugs.

The FDA's approval of Celltrion's Herzuma comes with a boxed warning - the regulator's harshest - on increased risks of cardiomyopathy and pulmonary toxicity among other things.

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

Earlier this year, the U.S. FDA declined to approve Pfizer's biosimilar of Herceptin.