UPDATED: Roche legal action messes with Mylan's India launch of its Herceptin biosimilar

The Swiss drugmaker says there hasn't been enough time for Mylan to meet India's rules for approval
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Last year, Roche ($RHHBY) appeared to throw in the towel on its breast cancer drug Herceptin in India when it said it would not defend the patent there. But it has come back out swinging with a court action that has messed with this week's launch of a biosimilar from Mylan ($MYL).

The Swiss drugmaker sued Mylan and partner Biocon, as well as the Drug Controller General of India (DCGI), which approved their drugs, the Economic Times reports. It claimed approval for their copies came too quickly for the drug companies to have followed India's 2012 guidelines for launching biosimilars. Biocon was set to launch its version next month. Roche argued that the Drug Controller approved Biocon's clinical trial design before it even completed its guidelines and that Biocon started on its trials before those guidelines were in place. The Delhi High Court responded with an injunction on the copies, saying their makers had to convince it that the drugs had been thoroughly tested.

The court ruled that Mylan and Biocon could not compare their drugs, CANMab and Hertraz, to Herceptin or its manufacturing process, safety, efficacy and sales when talking about their products, a Roche spokesperson told Reuters

In an emailed statement to FiercePharma, however, Mylan said it had learned about Roche's effort "aimed at hindering access to traztuzamab." It said that Mylan and Biocon were not given notice of the proceedings so were unable to be heard. "We do not believe that the injunction will prevent us from manufacturing and selling Hertraz, and we look forward to providing access to a more affordable, high quality treatment option to the thousands of women in India suffering from metastatic breast cancer." 

Biocon sent a statement saying, "It is an extremely shocking, but not unexpected development especially as Roche had decided not to pursue Indian patents for their breast cancer drug. This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab." 

Mylan said on Monday it had launched its version of the drug under the name of Hertraz and was celebrating the launch of the first copy of the drug. CEO Heather Bresch said that the company has provided regulators with extensive proof of its drug's "molecular similarity" and had "conducted a multicenter clinical trial to demonstrate comparable safety and efficacy to the reference product."

Roche has been battling over Herceptin in India for years. Herceptin earns Roche more than $6 billion a year worldwide and about $21 million in India for treating HER2-overexpressing breast cancer, the condition for which the biosimilar was approved. The cost of the drug has been criticized by healthcare activists in the country who say it keeps too many women from receiving the lifesaving treatment. The drugmaker responded by teaming with domestic Indian drugmaker Emcure Pharmaceuticals to produce a less costly version there. Last year, Roche cut Herceptin prices in India by 31% to $1,366 per month to make it more affordable.

Then in August, the Kolkata Patent Office denied Roche's patent, saying that it wasn't properly submitted. Roche surprised the market by saying it would not defend the patent, given that it had claimed it believed its patent was valid to 2019. While this left the window open for biosimilars, it was believed none were close to being ready. Three months later, Mylan and Biocon produced their own big reveal, saying they had biosimilars ready to go and that they had already received approval from the DCGI for their copies.

- read the Economic Times story
- here's Mylan's release 
- read the Reuters story

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