Will biosim naming hit Roche’s Avastin rep? Delhi Court doesn’t buy it

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Roche machinery.

A former law minister in India arguing for Swiss drugmaker Roche ($RHBBY) has been asked by the Delhi High Court to compile a brief supporting claims that the company faces reputational risk if an Indian firm uses the ingredient name of its major cancer blockbuster Avastin--"bevacizumab"--in a pending biosimilar.

Roche has filed a lawsuit in the Delhi High Court against the Drug Controller General of India to block any approval of a biosimilar labeled bevacizumab by Hyderabad-based Hetero Drugs.

Roche cited an April ruling by Delhi Court that Bangalore-based Biocon and U.S.-listed Mylan could not--for now at least--use the label biosimilar for versions of Roche's aging breast cancer treatment trastuzumab (Herceptin).

On May 20, the counsel for Roche in India, Kapil Sibal, argued that an approval for Hetero's drug as a biosimilar could cause harm if it is confused as the same as the originator.

The Economic Times reported that Sibal told the court Hetero was "piggy-backing" on proprietary data, and is not entitled to use the name bevacizumab.

"(Roche's) goodwill is associated with (bevacizumab) all over the world," Sibal was quoted as reported by the Economic Times. "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."

However, Judge Valmiki Mehta asked Sibal to compile a list of judgments that would support such legal intervention. with the hearing set to resume on Tuesday, May 24.

The hearing is being closely watched because of the potential for tighter intellectual property guidelines for biosimilars in India.

On the earlier breast cancer drug ruling in April, Roche said it: "Sent a strong, positive signal that the development, manufacture and approval of biosimilars in India must be subject to rigorous clinical and regulatory standards."

Biocon and Mylan plan to appeal the ruling, which hinges on the language on the packaging and any use of data from Roche's own work on trastuzumab in product inserts. In the meantime, the companies can continue to market the products with revised labels and packaging.

- here's the story from the Economic Times

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