Mylan appeals court’s interim order on Roche breast cancer drug

Drug-maker Mylan has appealed an interim order given by the Delhi High Court on its version of breast cancer drug Trastuzumab.

The High Court’s order allows Mylan to continue to manufacture and sell Hertraz - an affordable treatment for breast cancer, the multinational maker of generic and speciality drugs said.

“We are aware that the order places certain limitations with respect to packaging and labelling, but intend to challenge those limitations. We have filed an appeal,” a company spokesperson told BusinessLine .

Trastuzumab is Roche’s breast cancer drug which it sells under the brandname Herceptin. And earlier this week, the Court had allowed companies such as Biocon, Mylan and Reliance Lifesciences to sell their versions of the biological breast cancer drug, but disallowed them from claiming it is a “biosimilar” version of Roche’s Herceptin.

The United States Food and Drug Administration defines biologics as medicines that generally come from living organisms, including humans, animals and micro-organisms such as yeast and bacteria.

A biosimilar is a “highly similar” version of an approved biological drug. The tricky part here, however, is that they are complex, sensitive and way more difficult to make.

The situation becomes more complex, as biosimilars are priced less than the innovator drug.

While the Court did not prevent the generic drug-makers from selling their versions of trastuzumab, it restrained them from using innovator data relating to manufacturing process, safety, efficacy and tests conducted for the safety of the drugs, till a final decision on the issue of bio similarity was made in the present suit.

Generic companies could, however, make a come back and claim biosimilarity, the Court indicated, provided they furnished fresh data inline with the 2012 guidelines on biosimilars.

The case is being seen as a first of sorts in the biosimilar space in the country, even as countries across the world are still finding their way in terms of a regulatory pathway.

US-based Mylan had launched its version of Trastuzumab in India in early 2014, around the same time Biocon, with whom it has an alliance on the drug also launched the drug.

Reacting to the latest interim order, Biocon had said that its version of Trastuzumab, sold as CANMAb had undergone all applicable comparability studies.

At the time of launch, Biocon had priced the drug at ₹19,500 per vial for 150 mg and ₹57,500 for 440 mg, about 25 per cent less than the innovator’s price at that time.

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