MUMBAI: Swiss biotechnology giant Roche has sued the Drug Controller General of India in Delhi High Court along with Hyderabad-based Hetero Drugs over the process followed for approval of copies of complex biotech drugs or biosimilars of Avastin (bevacizumab), its blockbuster brand that is used to treat at least six forms of advanced cancers.Roche has challenged the regulator and pleaded to block the approvals of the drugs under review, ET learned from highly placed legal sources. The case was heard on Monday and is deferred till Friday. Avastin raked in close to $7 billion in global sales for the company.Roche’s latest salvo questioning India’s approval pathways for copies of popular biotech drugs is similar to the aggressive posture it took to defend its breast cancer drug Herceptin (trastuzumab), where it sued the drug regulator alongside Biocon , Mylan and Reliance Life Sciences. Roche did not comment on this issue.In that case, the Swiss drug maker had alleged that the guidelines for approval of such products outlined in 2012 were overlooked by the regulatory body. In an interim ruling delivered last month, the Delhi High Court sided with Roche but at the same time allowed the Indian companies to market their respective products on the condition of certain changes to the labelling and packaging of their products.Roche’s decision to litigate further on copies of Avastin is seen as a pre-emptive strike to prevent competition. Avastin is a treatment for debilitating ailments like colorectal cancer, non-small cell lung cancer , kidney cancer and ovarian cancer and at least three companies Intas Pharmaceuticals, Hetero Drugs and Reliance Lifesciences 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 April 7.The committee reviewed the Phase III clinical studies presented by Intas for bevacizumab in metastatic or recurrent non-small cell lung cancer and concluded that its efficacy was similar between the test arm and the reference arm. It added, “After detailed deliberation committee has recommended for the marketing authorization for the indication.” Taking a similar position, the committee recommended for approval bevacizumab for the use in metastatic colorectal cancer for the Hetero drug.However, the SEC recommendations is not the final signal for companies to commercialize their products. India follows a three-tiered process to approve new drugs. After the SEC go-ahead, the products are referenced to the Technical Committee, which is finally cleared by Apex Committee, a high-level group of experts.The Swiss drug maker had been under attack from health activists who saw the company’s stand as a tactical game plan to block competition from low cost variants. Roche on the other hand maintained its challenges are to ensure the safety of the patients.As cases of cancer is seeing an alarming rise in India with detection of over a million cases each year, the demand for affordable options for widely used anti-cancer drugs has spurted over the last few years. Several Indian drug makers are building new capacities and are in the queue for approval of a host of biosimilar products.>Roche sues DCGI for approval process followed for Avastin copies >Hetero, Intas and Reliance are leading the race for approvals from the DCGI >Avastin raked in over $7 billion in global sales>Due process of approval is not followed by the regulators >Could cause harm to patientsRoche is attempting to block low cost variants