Latest Headlines

Latest Headlines

Amgen's Neupogen won't face Novartis biosim till September: court

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.

Court blocks Novartis' biosimilar copy of Amgen's Neupogen

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.

Novartis gets bragging rights on first U.S. biosim. But will its Neupogen copy sell?

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.

FDA reviewers back Novartis biosim of Amgen's blockbuster Neupogen

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.

Amgen-Sandoz squabble over Neupogen copy could reshape biosim marketing

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 to whack 160 jobs

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.

Teva's Neupogen-knockoff approval highlights slow progress of biosims

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's Neupogen knockoff faces uphill battle for share

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.

Amgen founding CEO George Rathmann dies at 84

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.

Fake Avastin may not be the only counterfeit on doctors' shelves

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