The Drug Controller General of India has been moved court on by Roche, the Swiss biotechnology giant, in unison with Hyderabad-based Hetero Drugs on the process followed by the regulator for approval of complex biotech drugs or bio simmilars of Avastin (bevacizumab),its racy brand that treats six kinds of advanced cancer.
According to reliable sources Roche has pleaded for the blocking of drugs under review for approval; thereby, challenging the regulator. The case that was put up for hearing on Monday has been deferred till Friday. Avastin has raised a global sale worth $7billion for the company.
Prior to the current attack on the regulator regarding approval criteria for popular biotech drugs, Roche had taken an aggressive stand in defence of Herceptin (trastuzumab),its breast cancer drug. On this occasion it had collaborated with Biocon, Mylan and Reliance Life Sciences to put up a fight against the drug controller. Roche however was not forthcoming to comment on the same reports the Economic Times.
On a prior occasion of confrontation Roche had voiced its disapproval on the guidelines of approval of products publicized in 2012 to have been overlooked by the drug controller.
The high Court supported Roche on this matter.However,it allowed the Indian companies to market their respective products, though with certain changes in the labelling and packaging of the drugs.
It is believed that Roche’s endeavour in litigation seems to be driven by the intention to kill competition for Avastin. Avastin treats crippling diseases like colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer. Intas Pharmaceuticals, Hetero Drugs and Reliance Life Sciences are seen to be in the lead. Roche A Subject Expert Committee (SEC) under the Health Ministry had reviewed the applications of Intas and Hetero on 7th April.
The Phase III clinical studies presented by Intas for Bevacizumab in metastatic or recurrent non-small cell lung cancer have been reviewed by the committee, which has concluded that the efficacy between the test and reference arm was the same.
“After detailed deliberation the committee has recommended marketing authorization for the indication.” It added. Taking a similar position, the committee recommended for approval Bevacizumab (hetero drug) for use in metastatic colorectal cancer .
The SEC recommendations are not the final signal for companies to commercialize their products. A three-tiered process to approve new drugs is followed by India. After the SEC approval, the products are referenced to the Technical Committee whose approval is then cleared by the Apex Committee; a high-level group of experts .
Roche has been under attack from various health activists who see it as a giant trying to mitigate all competition from low cost manufacturers. However, the giant swears by patient safety.
With rising cancer statistics in the country several drug companies have joined the queue for approval of bio similar products within affordable range.