Roche presses on biosimilar labels in India with Avastin challenge

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Roche ($RHBBY) has stepped up its efforts to block approvals of copies of leading drugs labeled as biosimilars in India, pressing an advantage from a recent court ruling on Herceptin.

The Economic Times reports that the Swiss-based firm has filed a lawsuit in the Delhi High Court against the Drug Controller General of India to block any approval of a biosimilar label for Hyderabad-based Hetero Drugs in the case of bevacizumab (Avastin), the company's major-selling blockbuster cancer treatment. 

In April, the Delhi High Court said Bangalore-based Biocon and U.S.-listed Mylan could not use the label biosimilar for versions of Roche's aging breast cancer treatment trastuzumab (Herceptin).


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The case again highlights friction between multinational drug firms and Indian manufacturers over intellectual property rules. At the time of the April ruling, a Roche spokesman said that the court: "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.

The biosimilars of Herceptin were approved by the DGCI, with Roche now targeting that process for Avastin, the Economic Times said, citing sources. Roche was not immediately available for comment.

But the move is seen as a "pre-emptive strike" on Avastin specifically, as well as any other biosimilars brought into the local market in the same fashion, the newspaper said.

This is particularly the case for Avastin as other firms in India, Intas Pharmaceuticals and Reliance Life Sciences, are in the process of bringing product to the market. The Economic Times said applications for Intas and Hetero were reviewed by the DGCI on April 7 as the initial step in a three-tiered process.

- here's the story from the Economic Times

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