Company Statement: Delhi High Court Interim Order on Trastuzumab, March 03, 2017

“We are disappointed by today’s decision because it denies patients and physicians the right to make informed decisions about the treatment of breast cancer. Today’s decision means critical information about the clinical studies of our product Herceptin, marketed as Herclon in India, will be included on the packaging for these products even though there continues to be no evidence in the public domain that the companies producing these products have conducted the studies required for biosimilars. We believe it is important to ensure physicians and patients are not misled into believing these medicines will provide the same benefit and safety experience as our innovator medicine Herceptin.

As the holder of the Herceptin trademark and the innovator of Trastuzumab, Roche has a duty to its patients to ensure that a company that claims its products are comparable to ours have really followed and been assessed in relation to the rigorous clinical and regulatory standards outlined in the Indian Biosimilar Framework. The safety of patients will always remain a priority for Roche and we will continue to challenge companies that fail to present the data outlined in the Indian biosimilar framework.”