Roche sues Mylan over Herceptin biosimilar
Roche’s Indian subsidiary has sued Mylan and Bangalore-based pharmaceutical company Biocon at the Delhi High Court, for launching a biosimilar of its breast cancer drug Herceptin (trastuzumab).
It has also started a case against India’s Drug Controller General for allowing the launch.
Roche claimed that Mylan and Biocon’s drugs were being misrepresented as “trastuzumab”, “biosimilar trastuzumab” and as a “biosimilar version of Herceptin” without following the “due process in accordance with the Guidelines on Similar Biologics for the purpose of obtaining appropriate approvals.”
It also claimed that there is no public record that shows the firms conducted phase I and II clinical trials for the drug.
Until the next hearing, the court has ordered that Mylan and Biocon do not rely upon or refer to Herceptin, or any data relating to trastuzumab marketed as Herceptin for selling their own version of the drug.
“It is an extremely shocking, but not unexpected development, especially as Roche had decided not to pursue Indian patents for their breast cancer drug,” Biocon said in a statement.
“This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab. Canmab and Hertraz co-developed by Biocon and Mylan are world-class products that adhere to stringent quality standards and have been developed on the basis of applicable biosimilar guidelines.
“Biocon and Mylan are committed to affordability and access and are driven by their purpose of expanding the pool of patients that can afford trastuzumab. We are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand.”
A spokesperson for Roche told LSIPR: "This legal action is not a patent litigation. Rather, in taking this action we are seeking to clarify if Biocon and Mylan Inc.’s products have demonstrated comparable efficacy and safety to our innovator product trastuzumab, and have been approved as biosimilar products.
"We have taken this action because as the holder of the Herceptin trademark we have a duty to ensure that if a company claims its product is a biosimilar of or similar to our innovator product trastuzumab, that this really is the case."
The spokeperson continued: "As far as we are aware, 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."
He added: "Please note that while we have named the Drug Controller General of India (DCGI) as a party, our actions have not sought to challenge the approvals."
