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

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 market their product without any reference to Roche's product or biosimilarity. The division bench of Badar Durrez Ahmed and Sanjiv Sachdeva had modified a single judge order and allowed Biocon and Mylan to use the product insert for only metastatic breast cancer but without product data. Reliance and Cadila also sell this drug with different product inserts. This development paves the way to Biocon and Mylan to capture critical market share in the cancer drug therapy.

Roche, in a statement said, “We are disappointed by today’s decision because it denies patients and physicians the right to make informed decisions about the treatment of breast cancer. Today’s decision means critical information about the clinical studies of our product Herceptin, will be included on the packaging for these products, even though there continues to be no evidence in the public domain that the companies producing these products have conducted the studies required for biosimilars."

In an earlier hearing, the court had said that Swiss pharma major Roche could not prima facie have a say against the production and marketing of breast cancer medicines of drug firms Biocon and Mylan once the Drugs Controller General of India (DCGI) has approved it.

The observation of the court came after the DCGI, represented by Additional Solicitor General Sanjay Jain, had confirmed that the medicines and the package inserts of the two companies were granted approval for marketing and sale. The confirmation came in response to the court's query to DCGI on whether the package inserts of Biocon and Mylan have been approved by the authority.

The court was hearing the pleas of Roche and other pharma firms such as Biocon, Mylan and Reliance Life Sciences, on the issue of marketing and sale of generic drugs biosimilar to the Swiss company's Trastuzumab.

Roche's contention was that Biocon, Mylan and Reliance cannot term their medicine as merely Trastuzumab and ought to call it Biocon's Trastuzumab or Mylan's Trastuzumab as these companies have not followed the entire protocol of tests and studies, as was done by it.

Biocon argued back saying it manufactures the medicine for both the companies, but they sell it under different names. Biocon sells it as Canmab and Mylan sells it under the name of Hertraz. Both companies had mentioned the DCGI had asked them to quote the clinical data of Roche's cancer medication, Trastuzumab, in their respective package inserts, which are the slips of paper inside each medicine box containing details of the drug.