New Delhi High Court Allows Marketing of Biocon-Mylan Biosimilar of Trastuzumab

The New Delhi high court ruled that Biocon and Mylan can manufacture and sell the companies’ trastuzumab biosimilar to Roche’s biologic cancer treatment trastuzumab (Herceptin globally; Herclon and Bicletis in India) for the treatment of early breast cancer and metastatic gastric cancer—2 new indications that can now be added to an earlier approval of the biosimilar for treatment of metastatic breast cancer.

According to a previous court ruling, the companies could market their biosimilar trastuzumab only for treatment of metastatic breast cancer and could not use data from Roche’s Herceptin package inserts to market and guide treatment for the biosimilar in cancer indications that the reference drug is used for. The court was hearing an appeal by Biocon, and its partner Mylan, which had challenged an interim order restricting them from marketing trastuzumab for the additional indications. The Delhi high court ruling now allows the companies to use Roche’s product data in their biosimilar product’s package inserts. Roche had opposed some paragraphs from the product inserts about the additional indications and objected to their use of clinical tests conducted by Roche as being the biosimilar makers’ own data.

The Delhi high court decision stated that until there are any further court decisions, Biocon and Mylan are permitted to manufacture and sell biosimilar trastuzumab under their brand names for all 3 cancer indications “on the basis of the product inserts which have been approved by the competent authority.” Biocon counsel Pratibha Singh said the court has once again confirmed that there is no data exclusivity in India. Biocon founder Kiran Mazumdar Shaw said she hoped the order set a precedent for future such issues, and that the decision will pave the way for greater access to affordable biosimilar trastuzumab for cancer patients in India.

Roche had challenged Biocon/Mylan’s ability to market trastuzumab in India for the additional indications. The companies had litigated the use of Roche’s clinical trial data on the safety and efficacy of trastuzumab to treat early breast cancer and metastatic gastric cancer, with Roche’s attorneys arguing that the data were being used by Biocon and Mylan to “pass off” their brands as equally safe and effective without conducting their own clinical trials. For their part, Biocon and Mylan attorneys argued that the data used in the companies’ latest package insert were publicly available and not exclusive to Roche.

A statement from Roche said the Delhi high court’s decision meant that critical information about the clinical studies of Herceptin would be included on the packaging of biosimilars “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.” The company also said it was important to ensure that physicians and patients were not “misled into believing these medicines will provide the same benefit and safety experience” as Hercepin. Roche intends to continue challenging companies that fail to present data outlined in the Indian biosimilar framework.

The decision is expected to give the Biocon/Mylan trastuzumab biosimilar greater access to a Rs-300-crore (about $45 million) market in India.