Amgen and Allergan Study Finds Biosimilar Comparable to Herceptin

Amgen Inc. and Allergan PLC on Thursday said a late-stage trial of their treatment being developed as a biosimilar to Roche Holding AG's breast cancer drug Herceptin met its primary endpoint, another step in bringing cheaper versions of some of biotechnology's best-known cancer drugs to the market.

The study, evaluating the effectiveness and safety of ABP 980 compared with trastuzumab, the clinical name for Herceptin—a multibillion-dollar medicine that in the past two decades has transformed treatment for about 25% of breast-cancer patients—ruled out inferiority but couldn't rule out superiority.

"We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities," said Dr. Sean Harper, who leads research and development at Amgen. "Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we've generated supports ABP 980 as highly similar to the reference product."

The results from Amgen and Allergan—who are currently working together on the development and commercialization of four oncology biosimilars—come a month after researchers said a drug being developed by Mylan Pharmaceuticals Inc. proved comparable to Herceptin in a clinical trial.

Biotech drugs, which are typically injected or infused, are manufactured in living organisms, making them more difficult and costly to develop than standard pills made from chemicals. Showing that copies are essentially equivalent to the originals has also posed some scientific and regulatory challenges.

But the U.S. Food and Drug Administration, and European regulators recently established new regulatory criteria intended to create a market for biosimilars.

So far, the FDA has approved two biosimilar drugs under the initiative: Novartis AG's Zarxio, which is similar to Amgen's Neupogen for the treatment of side effects of chemotherapy; and Inflectra, a version of Johnson & Johnson's Remicade treatment for arthritis and other conditions. Inflectra was developed by Korea's Celltrion Inc. and licensed to Pfizer Inc.

Write to Anne Steele at [e-mail]

(END) Dow Jones Newswires

July 21, 2016 12:35 ET (16:35 GMT)

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