Roche Lawsuit Blocks Mylan's Herceptin Biosimilar

Feb 11, 2014

Swiss drugmaker Roche, which unexpectedly gave up its patent on its $6 billion breast cancer drug Herceptin (Trastuzumab) in India last year, is suing U.S. generic drugmaker Mylan and it's partner, Bangalore-based Biocon, as well as the Drug Controller General of India (DCGI), over the launch of the world's first biosimilar version of Trastuzumab in India.

According to the Economic Times of India, Roche contends that the Biocon/Mylan drugs are being misrepresented as 'biosimilar Trastuzumab' and 'biosimilar version of Herceptin' without following the 'due process in accordance with the guidelines on similar biologics' for getting approvals in India.

Roche further argued that there is no public record available to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

Biocon was set to start selling its biosimilar version of Roche’s blockbuster Herceptin later this month, however the Delhi High Court has issued an injunction delaying the launch from Biocon and Mylan until they had persuaded the court that their product had undergone sufficient testing.

Last August, Roche decided not to pursue a patent application for its breast cancer drug Herceptin in India, amongst rumblings from the Indian goverment that Roche had failed to secure additional patent protection because it did not follow the correct filing procedure.

Read the Economic Times release