Roche threw in the towel in trying to protect its patent for blockbuster cancer med Herceptin in India in August after a regulator there decided it was invalid. It left open the window for biosimilar makers to line up for that business, although there was some doubt in the industry about whether anyone was close to developing one. Mylan ($MYL) is ready to prove that wrong. Mylan said today that it and Indian biologics partner Biocon have nabbed the first approval there and will have a biosimilar of trastuzumab ready to roll out early next year.
The approval is for treating HER2 overexpressing breast cancer. "This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term," CEO Heather Bresch said.
Mylan said that Herceptin had sales of $21 million in India for the condition last year. That is only a sliver of the more than $6.34 billion in 2012 revenue the drug churned out. But it is on everyone's biosimilar "me-too" list because of its massive sales worldwide.
In August, the Kolkata Patent Office denied Roche's ($RHHBY) patent, saying that it hadn't been properly submitted. Roche said it would not defend the patent, which surprised the industry given that it had said it believed its patent was valid to 2019 and it already had taken steps to discourage the government from messing with its intellectual-property rights. It had teamed up with domestic drugmaker Emcure Pharmaceuticals to produce the drug in India, and the pair said they would roll out a less costly version of Herceptin. This year Roche also cut Herceptin prices in India by 31% to $1,366 per month to make it more affordable.
There was some uncertainty about whether any drugmakers would be able to come to the market anytime soon with a biosimilar of the complex drug, but Mylan and Biocon today said they were good to go with what is the duo's first approved biosimilar. Mylan will share revenue on the drug with Biocon in India, but under their arrangement, Mylan has exclusive marketing rights in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries if they can get approval in any of those countries. The drug is one of 5 products the duo are working on together.
- here's the release