Latest Headlines

Latest Headlines

Q3 beats on sales, earnings ready Amgen for biosimilar attack

Amgen is steeling itself against biosimilar competition to some of its top meds, with a biosimilar of its best-selling cancer drug Neupogen hitting the market in September and threatening to take a bite out of sales. But the company hasn't hit the eye of the storm just yet, as older products delivered Street-beating sales in the third quarter and new drugs showed potential in helping Amgen shore up its defenses.

Novartis finally gets to roll out inaugural biosim Zarxio. What will payers and docs do?

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.

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.