(Reuters) – The U.S. Food and Drug Administration on Friday approved Mylan NV’s biosimilar of Herceptin, Roche’s blockbuster treatment for breast cancer, making it the second copycat drug for cancer approved in the United States.
The FDA said Mylan’s drug Ogivri, which was co-developed with India’s Biocon, was the first biosimilar approved in the United States to treat breast or stomach cancer. (bit.ly/2zHuhul)
Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.
Mylan’s shares rose nearly 5 percent in afternoon trading on Friday amid a slide 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 Roche’s cancer medicines exceed $21 billion or over half its pharmaceuticals business sales but the drugs – Rituxan, Herceptin and Avastin – are coming under threat as their biosimilar versions get approval. The FDA in September approved Amgen Inc’s biosimilar of Avastin.
The FDA approved Mylan’s Ogivri to treat certain types of breast and stomach cancers.
Mylan and Biocon already sell Ogivri in 14 emerging markets and reached a settlement with Roche to launch the biosimilar in the major markets in March.
Reporting by Manas Mishra in Bengaluru; Editing by Savio D’Souza and Sai Sachin Ravikumar