NEW DELHI: The Delhi High Court on May 20 asked Swiss biotechnology giant Rocheto prove how it would be impacted if the government granted approvals for a biosimilar or copy of its blockbuster biotech drug bevacizumab . The drug, which Roche innovated and markets under the name ‘Avastin’, is used to treat at least six forms of advanced cancers.
The court was hearing Roche’s case to block approvals for a bevacizumab biosimilar by Hyderbad-based Hetero Drugscurrently under review. The company has challenged the Drugs Controller General of India ( DCGI ) along with Hetero Drugs over the process followed by a health ministry Subject Expert Committee (SEC) to recommend the copy for use in metatastic colorectal cancer.
Justice Valmiki Mehta, who was hearing the case, asked Roche’s counsel to explain its personal interest in the current approval process for Hetero Drug’s bevacizumab. “In a suit of this nature, you must have a personal or private interest,” he told Roche’s counsel.
The judge also asked the company to submit a compilation of judgments highlighting the protection given to drug innovators to support its call for legal intervention in the statutory process. The court will continue to hear the case on May 24.
Approving Hetero’s drug as a biosimilar to Roche’s blockbuster cancer drug would harm the Swiss company’s reputation as the SEC recommended the copy even while some phases of clinical trials were skipped, argued Roche’s counsel Kapil Sibal .
Hetero Drugs was “piggy-backing” on the Swiss giant’s proprietary data to pass off a drug that was not biosimilar to Roche’s and should therefore not be appropriated with the name ‘bevacizumab’, he further argued.
“(Roche’s) goodwill is associated with (bevacizumab) all over the world,” said Sibal. “Such misrepresentation is likely to deceive patients and doctors. If something goes wrong tomorrow (with Hetero’s drug in the market), (Roche’s) reputation is at stake,” he argued.
Roche’s Avastin has raked in $7 billion in global sales. The drug treats debilitating ailments like colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer. Hetero Drugs is one of two companies to have received an SEC recommendation for approval for a bevacizumab biosimilar, the other being Gujarat-based Intas Pharmaceuticals.
The companies would have to go through a Technical Committee and an Apex Committee before DCGI can approve their drugs as biosimilars for the Indian market. Roche has increasingly butted heads with the government over approvals given to other Indian companies for biosimilars of its biotech drugs.
The Delhi High Court on April 25 imposed conditions on Indian biotech drug makers Biocon and Mylan to sell copies of the Swiss company’s breast cancer drug, Herceptin (trastuzumab)— a move frowned upon by health activists who argued that it would affect the availability and affordability of the expensive treatment.
The court had ruled that the approvals to Biocon’s CANMAb and Mylan’s Hertraz were “not on the basis of adherence of the guidelines” and “rules framed under the Drug Act” and the drugs would have to be marketed without calling them biosimilar to Roche’s product in any manner.
The court on April 28 passed an interim order following an appeal by the companies, allowing them to continue marketing their drugs without calling them biosimilar to Roche’s product in any manner until July 21.