Last year, Roche 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.
Mylan turned to India's Biocon last year for expertise on making biosimilars. This year, the generic drug maker is turning to Biocon for someone to run its extensive operations in that country.
Mylan said today that it and Indian biologics partner Biocon have nabbed the first approval in India and will have a biosimilar of Herceptin (trastuzumab) ready to roll out early next year.
Syngene, the CRO arm of Indian biotech giant Biocon, is poised to swell about 20% a year, CEO Kiran Mazumdar-Shaw said, making it the continent's fastest-growing service provider.
India, facing its worst economic crisis in two decades, has in recent years invested little in basic infrastructure like power, water and roads. These shortcomings are forcing some of its most successful drugmakers to look outside the country when they need new manufacturing sites.
Now that the Swiss drugmaker has decided to forego a patent fight over the breast cancer drug in India, domestic drugmakers are rubbing their hands together in anticipation.
The company is looking for partners to expand commercialization of the therapy around the globe.
Biocon's Kiran Mazumdar-Shaw has been one of the leaders in India attempting to build a biotech community capable of developing drugs for worldwide markets. Now the company has a test case on its hands.
India's Biocon reported a huge fiscal year for its CRO arm, growing 36% over the previous year and becoming the largest clinical research provider in the country, the company said.
The two partners are keeping the specific terms under wrap, but Mylan agreed to share the development costs of the three programs in exchange for commercialization rights in the critical European and U.S. markets.