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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 

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

The Delhi High Court today permitted drug and to use product data for Trastuzumab, a generic biosimilar for The court said that and can market drugs for all three indications -- early breast cancer, metastatic and gastric had challenged the approval mechanism adopted by the central drug standards controller in giving and 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 and 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 and to use the product insert for only metastatic breast but without product data. Reliance and also sell this drug with different product inserts. This development paves the way to and to capture critical market share in the 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  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 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 medicines of drug firms 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 were granted approval for marketing and sale. The confirmation came in response to the court's query to on whether the package inserts of and have been approved by the authority.

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

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

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

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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

Delhi HC also allows them to use Trastuzumab data for breast, metastatic & gastric cancer therapy The Delhi High Court today permitted drug and to use product data for Trastuzumab, a generic biosimilar for The court said that and can market drugs for all three indications -- early breast cancer, metastatic and gastric had challenged the approval mechanism adopted by the central drug standards controller in giving and 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 and 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 and to use the product insert for only metastatic breast but without product data. Reliance and also sell this drug with different product inserts. This development paves the way to and to capture critical market share in the 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  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 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 medicines of drug firms 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 were granted approval for marketing and sale. The confirmation came in response to the court's query to on whether the package inserts of and have been approved by the authority.

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

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

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

The Delhi High Court today permitted drug and to use product data for Trastuzumab, a generic biosimilar for The court said that and can market drugs for all three indications -- early breast cancer, metastatic and gastric had challenged the approval mechanism adopted by the central drug standards controller in giving and 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 and 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 and to use the product insert for only metastatic breast but without product data. Reliance and also sell this drug with different product inserts. This development paves the way to and to capture critical market share in the 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  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 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 medicines of drug firms 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 were granted approval for marketing and sale. The confirmation came in response to the court's query to on whether the package inserts of and have been approved by the authority.

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

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

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

image
Business Standard
177 22