Roche Sues Biocon and Mylan Over A Biosimilar For Breast Cancer Drug; Injunction Granted By Delhi High Court

This story has been updated to reflect that the court order only applies to the use of certain trademarks and data belonging to Roche’s Herceptin. The generic versions of the drug, made by Mylan and Biocon, continue to be sold in the country. The original story had stated that a court order had banned the sale of generic versions of the breast cancer drug, Herceptin.

Swiss drug multinational Roche Holding Ltd (VTX:ROG) has won an injunction from the Delhi High Court restricting the use of certain trademarks and data related to Herceptin by drug makers Biocon Ltd (NSE:BIOCON) and Mylan Inc. (NASDAQ:MYL) who produce generic versions of the breast cancer drug. Roche also sued the Drug Controller General of India for approving the drugs in the first place.

Roche had filed a petition aiming to stop these cheaper versions of the breast cancer drug being sold as an alternative to the original. It argued that no public record was available to show that the rival companies had conducted phase-I and phase-II clinical trials for their drug, according to a report by the Economic Times. The “bio-similar” drugs by Biocon and Mylan were launched in the Indian market in January and early this week, respectively, and priced almost 30 percent lower than the original drug. The next hearing is slated for Feb. 28.

The Delhi High Court stated that CANMAb and HERTRAZ, developed by Biocon and Pennsylvania-based Mylan, cannot be compared with Roche’s drug Herceptin. Both the companies had stated that their products were the generic versions of the drug trastuzumab. The Delhi High Court ruled that no references, "including data relating to its manufacturing process, safety, efficacy and sales," could be made to Roche’s drug in marketing their own products.

Roche had decided not to seek a patent protection for Herceptin in India. Soon after that the Biocon-Mylan product was given an approval in November. Biocon, which is headquartered in Bangalore, said in a statement that the “proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab.” It added that CANMAb and HERTRAZ have been developed on the basis of applicable biosimilar guidelines.

The case throws light on the problems pharmaceutical giants are facing when it comes to patent protection for their drugs, giving their high margins for every dose due to their pricing. With biosimilars priced at a lower price than their drugs, the big companies lose out on money, with the customer buying cheaper versions.

Roche’s top-selling blood cancer treatment drug, Rituxan, also faces high probability of facing a biosimilar competitor soon. The drug earned 7 billion francs ($7.7 billion) in sales last year and Roche expects the biosimilar to hit the market by 2016.

For Herceptin, the company has a monopoly as of now in the Indian market; the drug generates more than $6 billion in sales globally for Roche. It had launched Herceptin at a price exceeding $2,000 per vial.