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 S. 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," Dr. Rugo said.

In a statement, Rajiv Malik, president of Mylan, said, "There is an urgent unmet need for more affordable versions of biologic products." But the company declined to discuss its pricing plans. Mylan is developing the drug in collaboration with Biocon Ltd. of India, where the Herceptin copy is already on the market.

How much insurers may ultimately save with biosimilars is unclear. Unless there are multiple biosimilars for a single branded drug, prices are expected to drop by only 15% to 30% from the branded drug's price. Another question is whether doctors and patients will be willing to switch to a biosimilar from Herceptin, an iconic breast cancer treatment.

Jonathan D. Rockoff contributed to this article.

Write to Ron Winslow at [e-mail] and Peter Loftus at [e-mail]

(END) Dow Jones Newswires

June 03, 2016 17:45 ET (21:45 GMT)

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