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Business News/ Companies / News/  Delhi HC allows Roche petition on breast cancer drug
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Delhi HC allows Roche petition on breast cancer drug

Roche sues DGCI for approving drugs; alleges regulator flouted laws

The court order followed a petition filed by Roche seeking to stop these low-cost breast cancer drugs being promoted as similar to the original. Aniruddha Chowdhury/MintPremium
The court order followed a petition filed by Roche seeking to stop these low-cost breast cancer drugs being promoted as similar to the original. Aniruddha Chowdhury/Mint

Mumbai: The Delhi High Court has restrained Biocon Ltd and the Indian unit of US generic drug maker Mylan Inc. from claiming that their cheaper breast cancer drugs are “bio-similar" versions of Herceptin, the cancer drug developed by Swiss-drug multinational F Hoffman La Roche Ltd.

The court order followed a petition filed by Roche Holding Ltd seeking to stop these low-cost breast cancer drugs being promoted as similar to the original.

Roche also sued the Drug Controller General of India (DGCI) for approving the drugs, alleging that the regulator flouted laws pertaining to the approval of bio-similar drugs in India.

Biocon and Mylan launched their bio-similar brands in the domestic market in January and early this week, respectively. The two companies introduced these drugs, branded as Canmab and Hertraz, claiming they were the world’s first bio-similar versions of Herceptin.

They were priced at least 30% lower than the original drug.

Roche’s petition alleges that research data submitted to the drug controller general by the company may have been leaked, as the generic drug companies Mylan and Biocon have not furnished any data pertaining to the early stage trials of the drug while seeking approval in India.

“Roche has filed and secured an injunction against Biocon and Mylan. The injunction prevents the companies from comparing their products to Herceptin," Roche spokesperson Daniel Grotzky said in an email response on Friday.

“In taking this action we are seeking to clarify if Biocon and Mylan Inc.’s products have demonstrated comparable efficacy and safety to our innovator product trastuzumab, and have been approved as biosimilar products. As the holder of the Herceptin trademark we have a duty to ensure that if a company claims its product is a biosimilar of or similar to our innovator product trastuzumab, that this really is the case," Grotzky said in the email.

A person familiar with the matter confirmed on Friday that Roche has sued DGCI for approving the cheaper drugs without following due diligence on quality and for relying on Roche data to qualify the decision of granting marketing approval to Biocon and Mylan for selling the low-cost drugs.

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Published: 07 Feb 2014, 12:35 PM IST
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