Roche gets break in case against India sales of cancer drug

The pharmaceutical world is now watching yet another battle between a drug innovator and a generic manufacturer. Swiss drug-maker Roche has challenged the validity of trials and approvals process for versions of its breast cancer drug Herceptin manufactured by Biocon and Mylan. The Delhi High Court (HC) has thrown a wrench into plans of Biocon and Mylan to market a breast cancer drug that goes by the scientific name Trastuzumab. While the Court has not stopped the manufacture of the drug outright, it has delivered an interim order saying Biocon and Mylan cannot compare their versions of the drug to Roche's original Herceptin, or use the brand name. But the problem is that Biocon and Mylan can only market their biosimilars by linking it to the original compound.Remember, Roche had moved court questioning the clinical data used to get approvals for these versions. It argued that since India's guidelines for biosimilar approvals came only in 2012, Biocon could not have followed the "due process" and received approvals in such a short period.Roche in a statement to CNBC-TV18 says: "The Indian regulatory authorities have approved Biocon and Mylan Inc.'s products as trastuzumab, as per their regulatory process, but it is unclear if the products meet the criteria for biosimilar products... We are seeking to clarify if Biocon and Mylan Inc.'s products have demonstrated comparable efficacy and safety to our innovator product trastuzumab.” Roche has also named the Indian drug regulator in the case, but has told CNBC-TV18 that it is not challenging the approvals. Biocon and Mylan were not available for comment.However, lawyers say Biocon and Mylan may have some ground to stand on since there is no law stopping them from using Roche's data on Trastuzumab's process and safety studies.Rajeshwari Hariharan, Partner, Rajeshwari & Associates says: “In India we don’t have the data exclusivity regime. So, when a company does clinical trials & generates some data & that data is submitted to the drug controller, there is no law in India that specifically prohibits another company from relying upon such information. There is a scope for challenge and it should be challenged because if this trend continues it would become very difficult for other biosimilars to be launched.”The high court order comes as some relief for Roche. It will continue to hold a monopoly in the Indian markets despite giving up patent protection for the drug in India after it was included in the government's Cumpulsory License list a year ago.But patient aid groups say Roche's case is a ploy to delay generic versions from hitting the markets.Kalyani Menon-Sen, Coordinator, Campaign for Affordable Trastuzumab says “This move by Roche bears out our contention that the guidelines are weighted against innovators in developing countries, and are likely to be used by big pharma to protect its own interests rather than ensure the safety and efficacy of biosimilars.”Hearing in the case will continue on February 28 and experts say arguments are likely to centre around Biocon and Mylan challenging this order.