The Delhi High Court today refrained from staying its single judge's interim direction allowing manufacture and marketing of breast cancer drug Trastuzumab by pharma firms Biocon and Mylan imposing certain restrictions on packaging and labelling and regulatory process.
The division bench of the high court, however, said the drug-makers may continue to sell their products under the brand names, which they were doing prior to the order passed by the single judge on April 25.
"The petitioners (Biocon Ltd and Mylan Pharmaceuticals Pvt Ltd) shall continue to operate till next date date of hearing on May 10, in the manner they were operating prior to the judgement dated April 25," a bench of justices B D Ahmed and Sanjeev Sachdeva said.
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The court's direction came on pleas by Biocon and Mylan, who sought setting aside of findings of the single judge, which allowed them to sell their versions of Trastuzumab but disallowed them from claiming it to be a bio-similar version of Roche's Herceptin.
Swiss pharmaceutical firm Roche's breast cancer drug Trastuzumab is sold under the brand name Herceptin.
They have also challenged the single judge direction that the two can use the international nonproprietary name (INN), an official generic and nonproprietary name given to a drug or active ingredient, as Biocon's Trastuzumab or Mylan's Trastuzumab wherever applicable to describe the composition of molecule on the product as well as in its insert and not in a prominent manner.
"The said expression shall be used at the bottom part of the carton and should be in small size letters than their respective brand names," the single judge had said.
It had also said Biocon and Mylan are restrained from using data relating to manufacturing process, safety, efficacy and tests conducted for the safety of the drugs as complained of by the plaintiffs till the time the final decision on the issue of the bio similarity is made in the present suit.
Taking note of which, the bench said this matter requires consideration.
The single judge had allowed Biocon and Mylan to continue with manufacture and marketing of their breast cancer drug under their brand names 'CANMAb' and 'HERTRAZ'.
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The single judge had made it clear that these companies would not call their product as bio-similar to Herceptin, Herclon, Biceltis, the brand names of Roche.
The court while passing the order on a petition filed by Roche against Biocon and Mylan had said, "They need to follow stringent guidelines framed in 2012 for getting regulatory approvals."
Roche had filed the petition seeking injunction alleging that there was an imminent threat of introduction of purported biosimilar version of its biological drug Trastuzumab, which was claimed to have been jointly developed by Biocon and Mylan under their brand names CANMAb and HERTRAZ.
