Indian States Halt Off-Label Use of Roche Avastin

Jan. 20, 2016

India's Gujarat and Telangana states halted sales of Roche's blockbuster drug Avastin, after it hampered the vision of 15 patients who used it for a condition it had not been FDA-approved to treat.

Avastin, approved as a cancer drug, is often used by doctors to treat wet age-related macular degeneration (AMD).

Roche has been opposed to this off-label use, claiming it "bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries around the world."

Roche's assertion of the dangers of off-label use was challenged in 2014, when Italian antitrust authorities fined Novartis and Roche Holdings a total of $250 million for allegedly colluding to prevent the use of Roche’s Avastin cancer drug as a treatment for eye disease, in favor of their more expensive drug, Lucentis. The companies allegedly created an "artificial distinction" between the two drugs by exaggerating the dangers of Avastin.

Read the Reuters release