Roche Prohibits Rivals Biosimilars Comparison To Cancer Drug Herceptin

Roche has won an injunction from an Indian court forbidding rivals Biocon and Mylan from comparing their generic versions to Roche’s cancer treatment Herceptin (trastuzumab). Mylan and Biocon co-developed Herceptin biosimilars CANMab and Hertraz.

“Roche has filed and secured an injunction against Biocon and Mylan. The injunction prevents the companies from comparing their products to Herceptin,” a Roche spokeswoman stated in an email. The injunction requires the two generic drug makers to refrain from referring to Herceptin when communicating about their generic versions’ safety and efficacy. The same injunction applies when the companies communicate about CANMab and Hertraz’s manufacturing process or sales.

Pharmaceutical group Roche has resolved not to submit a patent application for Herceptin in India. The decision has opened the door for generic drug makers to manufacture less expensive versions of the cancer treatment. Biocon and Mylan launched their generic versions about a year following Roche’s decision. The company said the injunction will serve to ensure its rivals’ products meet the biosimilars criteria of safety and efficacy compared to Herceptin.

Herceptin is indicated in patients with early stage breast cancer classified as Human Epidermal growth factor Receptor 2-positive (HER2+) and which has either spread or not spread into the lymph nodes. An estimated one in four breast cancer patients has HER2+ breast cancer. The drug is also approved in treatment of gastric cancer when combined with chemotherapy in patients who have not undergone prior treatments for either capecitabine or HER2+ metastatic cancer of the stomach or gastroesophageal junction.

Biocon has responded to Roche’s move, saying it was an extremely shocking but not quite unexpected development. “We are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand,” the India-based company said.

Biocon also added that Roche was only trying to stop patients from accessing less expensive versions of the drug. U.S.-based Mylan has not yet given any statement regarding Roche’s move.

Source:

http://finance.yahoo.com/news/roche-bans-rivals-comparing-copycat-163344707.html