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Setback for Roche: Mylan, Biocon can now sell generics of its cancer drug

Delhi HC also allows them to use Trastuzumab data for breast, metastatic & gastric cancer therapy

Sayan Ghosal/Veena Mani  |  New Delhi 

The Delhi High Court today permitted drug companies Biocon and Mylan to use product data for Trastuzumab, a generic biosimilar for cancer. The court said that Biocon and Mylan can market cancer drugs for all three indications -- early breast cancer, metastatic cancer and gastric cancer. Roche had challenged the approval mechanism adopted by the central drug standards controller in giving Biocon and Mylan approval for its biosimilar drug and its inserts containing product data before the single judge. Earlier the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to ...

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