Novartis said on Tuesday in its earnings announcement that two Sandoz plants in India had been nailed last week with a warning letter. CEO Joseph Jimenez said the FDA issued the warning letter for the sites in Kalwe as well as one in Turbhe, a plant that Sandoz intends to close.
Swiss-based Novartis will close a manufacturing plant in India, CEO Joe Jimenez said on the Oct. 27 third quarter earnings call, noting that the company has moved on remediation plans following inspections, but still received a U.S. FDA warning letter.
Two weeks ago, Novartis launched a copy of Amgen's Neupogen (filgrastim), its first in what it expects to be a thriving business in biosimilars, in the U.S. In anticipation of big sales, its Sandoz unit has now opened a plant in Austria to make the autoinjectors that will dispense the drugs.
The age of biosimilars in the U.S. has finally dawned with the launch of Novartis' Zarxio, a copy of Amgen's Neupogen (filgrastim). And it's arriving with a 15% discount to win scripts over from the brand.
A 10% revenue expansion in Novartis' generics unit Sandoz was one of the positives in the Swiss drugmaker's second quarter earnings, but it will not keep the drugmaker from closing three Sandoz plants next year and cutting about 770 jobs to improve margins even more.
Novartis's generics business Sandoz provided the key bright spot in an otherwise tough earnings report for the Swiss pharma, with revenues up 10%. But the starring performance did not keep the manufacturing side of Sandoz from getting spanked, with three of its plants now targeted for closing.
Novartis' Sandoz may have the first FDA-approved biosimilar in Zarxio, but it doesn't have permission to launch--and it won't be getting that until September, the country's top patent court ruled Tuesday.
The launch for Glatopa, the new generic of Teva's Copaxone from Novartis' Sandoz, is still in the very early going. But so far, things look good--very good.
Novartis CEO Joe Jimenez said in March the company would have another go at significant cost cuts in the wake of its asset swap with GlaxoSmithKline. Manufacturing was one area where it expected to tighten up, and a plant in India is now on the chopping block along with 170 jobs.
Novartis CEO Joe Jimenez took a swipe at Sandoz's Indian competitors last year, suggesting there would be fallout in the generics market as smaller players were unable to "build quality into their systems" to meet rising regulatory demands. Now a Sandoz plant in India is having its own issues, recalling more than 1 million packages of a generic of the number one selling allergy pill Zyrtec.