Study Finds Mylan’s ‘Biosimilar’ Drug Comparable to Roche Cancer Medicine

CHICAGO—Researchers said a drug being developed by Mylan Pharmaceuticals Inc. proved comparable to Roche Holding AG’s Herceptin in a clinical trial, a new milestone in the effort to bring cheaper versions of some of biotechnology’s best-known cancer drugs to the market.

In a study involving a total of 500 patients, Mylan’s drug, called Myl-1401O, was shown to be essentially equivalent in safety and effectiveness to Herceptin, a multibillion-dollar medicine that in the past two decades has transformed treatment for about 25% of breast-cancer patients.

Mylan’s drug is a so-called biosimilar—the industry’s term for a copy of a biotechnology drug.

The copy “has the potential to meet the need for an affordable treatment option” for women diagnosed with what is known as Her2-positive breast cancer, said Hope Rugo, lead author of the report and professor of medicine at University of California San Francisco.

“We haven’t been able to deliver lifesaving therapies around the world because of cost,” she said.

Dr. Rugo presented the findings—the first to show a biosimilar drug is equivalent to a biotech drug designed to attack cancer—at the annual meeting of the American Society of Clinical Oncology on Friday.

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