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    Delhi High Court gives Biocon, Mylan green light to market blockbuster biosimilar for three cancers

    Synopsis

    The court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and Mylan to grab more revenue.

    ET Bureau
    NEW DELHI: The Delhi High Court has allowed Biocon and Mylan to sell their copies of Swiss giant Roche's blockbuster cancer drug ‘trastuzumab’ to treat three types of cancers, giving the biotech majors greater access to a Rs-300-crore potential market.

    According to an earlier court ruling, both companies could sell the drug to treat only one type of cancer and could not use the data of Roche’s own trastuzumab in package inserts for their brands ‘CANMab’ and ‘Hertraz’.

    The court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and Mylan to grab more revenue in the cancer therapy market.

    A division bench comprising Justices Badar Durrez Ahmed and Sanjeev Sachdeva on Friday passed an interim order permitting Biocon and Mylan to sell their trastuzumab brands to treat metastatic breast cancer, early breast cancer and metastatic gastric cancer. So far, Biocon and Mylan were marketing their trastuzumab brands for only metastatic breast cancer.

    Image article boday


    In the meantime, the companies are expected to maintain accounts on sales of their trastuzumab brands.

    The order supersedes all previous interim orders on the issue, said the judges. They are expected to hear the case next on March 30.

    The court allowed Biocon and Mylan to market their products for the additional cancers based on approvals granted by the Drug Controller General of India (DCGI), India’s apex drug regulator, to manufacture, sell and market their brands as ‘biosimilar’ to Roche’s own trastuzumab brands. Government’s counsel Additional Solicitor General (ASG) Sanjay Jain told the court that DCGI had further approved package inserts that would allow the companies to sell CANMab and Hertraz to treat all three cancers.

    A ‘biosimilar’ is a copy of a complex drug made of living cells.

    Roche, which invented trastuzumab, sells it under the brand names ‘Herclon’ and ‘Biceltis’ in India and as Herceptin globally.

    The judges also raised questions over Roche’s lawsuit against the companies and DCGI.

    The interim order was passed after counsels of Roche, Biocon and Mylan debated the use of Roche’s clinical trial data on the safety and efficacy of trastuzumab to treat early breast cancer and metastatic gastric cancer. Roche’s counsels argued that the data were being used by Biocon and Mylan to pass their own brands off as equally safe and effective without the companies doing their own clinical tests.

    Counsels for Biocon and Mylan, on the other hand, argued that the data used in the companies’ latest package insert were publicly available, and not exclusive to Roche. “The court has once again confirmed that there is no data exclusivity in India,” Pratibha Singh, counsel for Biocon, told ET.

    “This is a case that should have gone through the regulatory appellate board, and I hope this (order) sets a precedent for future such issues,” Biocon founder Kiran Mazumdar Shaw told ET.

    "We see this as a significant positive development which will pave the way fo greater access to affordable biosimilar trastuzumab for cancer patients in India," stated a company spokesperson. CANMab has been developed as per existing Indian biosimilar guidelines and was introduced in the market in 2014 after clinical studies and necessary regulatory approvals were obtained, the spokesperson added.

    Biocon’s share price on the Bombay Stock Exchange rose 3.76% to close at Rs1,072.75 on Friday following the order.

    “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,” stated Roche in an official release following the order. “We believe it is important to ensure physicians and patients are not misled into believing these medicines will provide the same benefit and safety experience as our innovator medicine Herceptin.”

    Roche added that it would continue to challenge companies that fail to present data outlined in the Indian biosimilar framework.

    Mylan did not respond to ET’s emailed queries by the time this report went for publication.

    Since 2014, Biocon and Mylan have been locked in a legal tussle against Roche over their approvals to sell copies of the Swiss company’s trastuzumab brands.

    The biotech majors had approached the Delhi High Court last year to appeal an April 25, 2016, order by Justice Manmohan Singh that ruled Biocon's CANMab and Mylan's Hertraz could not be called "biosimilar" or ascribe any biosimilarity to Herceptin, Herclon or Biceltis.

    The order had restrained the biosimilar makers from using data relating to the manufacturing process, safety, efficacy and tests until a final decision is made on the issue of their biosimilarity.

    The order had also called into question the processes followed by the Indian drug controller to approve the drugs as biosimilars. The division bench stayed this order on April 28, 2016.

    The appeal proceedings are still ongoing at the Delhi court.

    Apart from Biocon and Mylan, Reliance Life Sciences has also approached the court to appeal a similar order against their trastuzumab drug. This appeal is expected to be heard on March 30.


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    ( Originally published on Mar 03, 2017 )
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