The Supreme Court (SC) ruling that puts a halt to clinical trials in India until the monitoring system is in place is a huge deterrent to drug innovation that can have an irretrievable impact on India's ability to partake in new drug development as it will lead to an exodus of innovators from India!, stated Kiran Mazumdar Shaw, CMD, Biocon.

It is imperative that clinical trials are conducted on Indian patients to establish safety and efficacy of new drugs on our ethnic population to ensure access to new medicines.

As an innovation-led company, Biocon has several innovative programmes in the clinic. Most of these are global programmes, in keeping with our strategy of delivering high quality yet affordable biopharmaceuticals to patients across geographies, beginning with India and other emerging markets. “While the overall impact of this Supreme Court ruling will not be on the global development of our programs but the Indian trials would be affected. Our clinical development is focused on global markets with early trials in India, these will have to now wait,” she said.

On whether the SC ruling would lead to companies to immediately look to transfer studies to global sites, the Biocon chief stated that these business decisions were not taken on an ad-hoc basis. “All our decisions, whether related to clinical trials or otherwise, are taken with a long-term perspective.”

“In fact, all our research assets are being developed for global markets. In the case of biosimilars we have ongoing trials for insulins, analogs and MAbs. For instance the global phase III trial for biosimilar Trastuzumab has commenced in major European countries. In India, we have completed patient recruitment for a separate phase III trial for biosimilar Trastuzumab and expect to file for regulatory approval with the Drugs Controller General of India (DCGI) in 2014. Since it’s a biosimilar and not a new molecule we hope it will not face regulatory hurdles,” Shaw told Pharmabiz in an email interaction.

“In the case of our novel biologic Itolizumab, which we recently launched in India as AlzuMAb for the treatment of psoriasis, we have preclinical data that supports its effectiveness in several other autoimmune diseases. However, we had plans to conduct additional trials in India for other indications like rheumatoid arthritis and multiple sclerosis, these will have to now wait,” she said.

Biocon is committed to extending the benefit of Itolizumab to global markets, for multiple autoimmune indications through strategic collaborations to ensure our innovative asset reaches patients. Global partnership discussions are on and if India does not become favourable to clinical trials soon, we will certainly be denying patients here access to this new line of treatment for several autoimmune diseases like rheumatoid arthritis, multiple sclerosis etc., she pointed out.