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.
Last month, a U.S. appeals court blocked Novartis' biosimilar version of Amgen's blockbuster Neupogen while the companies worked out a patent dispute. Unsurprisingly, though, Novartis wants that ban lifted, and now it's asking the court to do just that.
Novartis' plant in Stryków, Poland, one of the largest of its Sandoz generics unit, had no packaging lines, forcing the company to transport its production to other facilities for that step in the supply chain. Sandoz will be able to expand capacity at the plant and save on transportation costs now that it has opened a new packaging facility there.
Generics makers have been champing at the bit to get a copy out of Teva's Copaxone, the best-selling multiple sclerosis med that generated $4.2 billion in revenue last year. But according to Momenta CEO Craig Wheeler, his company's version--a joint effort with partner Sandoz, Novartis' generics unit--may be the only knockoff around for a while.
The cost of multiple sclerosis drugs has skyrocketed over the past 20 years, and it's not just new drugs driving that increase. Not one MS drug has a list price of less than $50,000 per year in the U.S., and some treatments cost 7 times more now than they did in 1995, a new study found.
It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
Novartis and its Neupogen biosimilar are steamrolling toward the U.S. market. But Amgen hasn't given up stopping the product in its tracks. The biotech last week urged a California court to block the biosimilar launch, with FDA approval expected as soon as March 9.
The ripple effects from last week's Teva v. Sandoz ruling have begun. The U.S. Supreme Court sent three patent fights back to a lower court in light of that ruling, which ordered the Federal Circuit Court to defer to district-level findings on patent claims unless a "clear error" had been made.
Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.
Novartis' generic division, Sandoz, is having to recall one lot of its generic version of Novartis' blood pressure drug Atacand, but it is a copy that it does not manufacture itself. The drug is made in India by Mylan.