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.
Amgen is none too eager for Novartis to roll out its newly FDA-approved biosimilar version of its blockbuster Neupogen, and for now, it's getting its way: A U.S. appeals court has blocked sales of the copycat while the companies resolve a patent dispute.
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.
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.
The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.
Amgen's earnings last week were not half bad. But they were not good enough to save the jobs of 160 employees whom the company says it will let go.
The FDA has handed an approval to Teva for its biosimilar of the aging neutropenia drug Neupogen. But the significant barriers that lie between that treatment--tbo-filgrastim--and any kind of significant market share underscores just how slowly these new therapies will begin to reshape the U.S. drug market.
Teva Pharmaceutical Industries ($TEVA) has pegged its future on becoming a hybrid drugmaker, with generics and brands working in perfect synergy. That's because it has looked past the huge wave of patent expirations on blockbuster drugs, and concluded that generics growth alone won't be respectable enough. And that's why it bought Cephalon last year.
In the years after he took the helm of the company, Rathmann helped steer the development of Epogen and Neupogen. Only now does Amgen face rivals to its anemia franchise.
As doctors search their shelves for the counterfeit Avastin flagged by Roche ($RHHBY) and the FDA yesterday, officials are also hunting down illegally imported, unauthorized versions of other pricey