In setback to Roche, Biocon, Mylan get HC nod to sell cancer drug

The Delhi High Court on Friday permitted pharmaceutical companies Biocon Limited and Mylan to market and sell biosimilar variants of cancer drug trastuzumab using packaging inserts containing publicly available data for the treatment of two additional kinds of cancer.

The division Bench of judges Badar Durrez Ahmed and Sanjeev Sachdeva allowed the pharma firms the relief after holding that the Drug Controller General of India (DCGI) had approved their drugs as biosimilars of Swiss pharma major Roche’s trastuzumab and permitted the package inserts indicating their use in cases of Her2 metastatic breast cancer, early breast cancer and metastatic gastric cancer.

Roche Products (India) Private Limited had in 2015, moved the high court against Biocon and Mylan’s references of biosimilarity to Roche’s cancer drug trastuzumab in marketing of their own versions, Canmab and Hertraz, respectively. Roche had also challenged the mechanism adopted by DCGI in granting approvals to the rival companies, as well as the use of Roche’s product data in the package inserts for the competing products.

This development now paves the way for Biocon and Mylan to make significant advancements in the cancer drug market. Reliance Life Sciences and Cadila Healthcare also sell Trastuzumab, but with different product inserts. A biosimilar product is a complex biological product that follows a different approval pathway as compared to chemical drugs. The process usually involves the testing of the drug on animal and human subjects to demonstrate its similarity with the original innovator’s product in terms of safety and efficacy.

Roche stated, “We are disappointed by today’s (Friday’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 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.”