Amgen and Allergan Study Finds Biosimilar Comparable to Herceptin
22 July 2016 - 2:37AM
Dow Jones News
By Anne Steele
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 Anne.Steele@wsj.com
(END) Dow Jones Newswires
July 21, 2016 12:22 ET (16:22 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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