The Delhi High Court has allowed biotech majors Biocon and Mylan to sell their copies of Swiss biotech giant Roche’s blockbuster cancer drug ‘trastuzumab’ to treat three types of cancers. The companies were previously restricted to selling this drug to treat only one cancer due to an earlier court order that prevented them from using 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. According to an industry executive, the trastuzumab markalone is valued at nearly Rs 300 crore.
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. In the meantime, the companies are expected to maintain accounts with regards to sales of their trastuzumab brands.
So far, Biocon and Mylan were marketing their trastuzumab brands for only metastatic breast cancer.
The order supersedes all previous interim orders on the issue, said the judges. They are expected to hear the case next on March 31.
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 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 the Indian drug regulator that approved their trastuzumab brands and gave them the green light to market them as a biosimilar to the Swiss firm’s trastuzumab brands.
“…This is not a case of patent, but you’re disguising it as one,, Justice Ahmed told Rajiv Nayyar, Roche’s counsel.
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 was being used by Biocon and Mylan to pass their own brands off as equally safe and effective without the companies having done their own clinical tests to ascertain the same.
Counsels for Biocon and Mylan, on the other hand, argued that the data used in the companies’ latest package insert was publicly available data which was not exclusive to Roche. “The court has once again confirmed that there is no data exclusivity in India,, Pratibha Singh, one of the counsels 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. Biocon’s share price on the Bombay Stock Exchange rose 3.76% to close at Rs1,072.75 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.
Biocon and Mylan have been locked in a legal tussle against Roche over their approvals to sell copies of Roche’s trastuzumab brands since 2014.
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 till the time 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 court to appeal a similar order against their trastuzumab drug. This appeal is expected to be heard on March 31.