Delhi High Court Permits Biocon And Mylan To Sell Cancer Drugs As Biosimilars
The Delhi High Court passed an interim order on Friday allowing drug manufacturers Biocon Ltd. and Mylan Pharmaceuticals Pvt. Ltd. to claim biosimilarity with Swiss pharmaceutical company Roche's Trastuzumab drug. The medicines are used to treat breast and stomach cancer.
“We see this as a significant positive development which will pave the way for greater access to affordable biosimilar trastuzumab for cancer patients in India, said Biocon in a media statement to BloombergQuint.
Roche said in a statement that it was “disappointed with Indian court's decision”, according to Bloomberg.
A biosimilar is a biological product approved based on a showing that it is highly similar to an FDA-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness, according to U.S. Food and Drug Administration's (U.S. FDA) website.
The high court order came after the two companies had challenged an earlier order passed in April 2016. The judge had then ruled that Biocon and Mylan could not claim biosimilarity to Roche's Herceptin (Trastuzumab) drug and barred them from using Roche's data to sell their drugs.
Roche had filed an objection in the high court claiming that Biocon's CANMAB and Mylan's Hertraz are not biosimilars of the Trastuzumab drug.
Friday's interim order, passed by the two-judge division bench, allows Biocon and Mylan to make and sell the two drugs as biosimilars.
Shares of Biocon Ltd. gained as much as 5.3 percent intraday and were trading at Rs 1,078 apiece on the Bombay Stock Exchange at 2.09 p.m.
The interim order may not be a very big positive for Biocon, which already sells the drug in India and may contribute between Rs 30-40 crore to Biocon's business in India, Surya Patra, an analyst with brokerage Philip Securities told BloombergQuint on the phone.
The next date of the hearing is on March 30, 2017.
An earlier version of the story inadvertently quoted Surya Patra as saying that the size of the Trastuzumab market is Rs 30-40 crore.
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