Roche fights back on Herceptin biosimilar

Roche (SIX:ROG; OCTQX:RHHBY) filed suit in India against the Drugs Controller General of India (DCGI), Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) and Mylan Inc. (NASDAQ:MYL) "seeking to clarify" that the partners "have demonstrated comparable efficacy and safety" of Canmab/Hertraz with Roche's breast cancer drug Herceptin trastuzumab. DCGI approved Canmab/Hertraz as a biosimilar of trastuzumab for HER2-positive metastatic breast cancer in November, but Roche said that "based on the limited data in the public domain and results from an unpublished 132 patient study," it is "unclear how Biocon and Mylan Inc.'s products would fulfil the requirements for biosimilar products" (see BioCentury Extra, Nov. 26, 2013).

The High Court of Delhi granted an injunction that Roche said prevents Biocon and Mylan from comparing Canmab/Hertraz to Herceptin. Mylan said the injunction places "limitations on the use of certain trademarks and data" but does not believe the injunction prevents it from selling Hertraz, which the company launched in India earlier this week. Biocon has said it plans to launch Canmab this month. Mylan and Biocon are co-developing a Herceptin biosimilar under a 2009 deal. Mylan, Biocon and Roche all declined to disclose specific next steps. ...