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Biocon restrained from claiming breast cancer treatment drug is biosimilar for Herceptin

3:54 am by | 0 Comments

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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 treatment 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 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 that 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.

A person familiar with the matter confirmed on Friday that it has sued the drug authority in India for approving the cheaper drugs without following due diligence on the 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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By C. H. Unnikrishnan

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