Last week, Novartis' Sandoz unveiled weak numbers, blaming them on broader generics-industry trends. But at least one analyst isn't convinced that's the culprit.
Over-the-counter specialist Perrigo said on Monday that it was recalling some of its children's grape-flavored Mucinex copies after learning that dosing cups may be mismarked, putting children at risk for being overdosed. It said for some children, taking too much of the med could lead to vomiting and other stomach problems.
The launch of the first biosimilar in the U.S., Sandoz's Zarxio, has stimulated tremendous market opportunities, with sales predictions for biosimilars pointing to $25 billion by 2020, according to a 2014 Thomson Reuters report.
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.