(Reuters) – The U.S. Food and Drug Administration on Friday approved Mylan NV’s biosimilar version of Roche’s blockbuster breast cancer treatment Herceptin.
The FDA said Mylan’s Ogivri is the first biosimilar approved in the United States to treat breast cancer or stomach cancer and the second approved to treat cancer. (bit.ly/2zHuhul)
Mylan’s shares were up about 3 percent in late morning trading amid a drop in the broader market.
Herceptin is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years.
Annual sales of the Roche’s cancer medicines – Rituxan, Herceptin and Avastin – top $21 billion, or more than half of its pharmaceuticals business, but are under threat as their biosimilar versions get approval.
Biosmilars are a copycat of the original treatment and are just as effective, but cheaper.
The FDA in September approved Amgen Inc’s biosimilar version of Avastin.
Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Savio D’Souza