Tag Archives: Sandoz

Sandoz Launches First Biosimilar Drug in U.S.

Posted on September 4, 2015 by Warren Woessner

A new chapter in the generics/innovator wars began Thursday as Sandoz, Novartis’ generics division launched its Neupogen biosimilar, Zarxio, in the U.S. at about a 15-30% discount from the price of Neupogen. While biosimilars have been marketed in Europe since 2006, Congress … Continue reading →

Posted in Biosimilars | Tagged Biosimilars, biotechnology, biotechnology law, biotechnology news, intellectual property, ip, Novartis, Patent Law, patents, Sandoz, Warren Woessner, Zarxio | Leave a comment

Novartis Wins Landmark Biosimilar Approval

Posted on March 9, 2015 by Warren Woessner

Novartis Navigates The FDA-ACA Maze – Gets Approval For Generic Neuprogen. Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). … Continue reading →

Posted in Patent Eligible Subject Matter | Tagged Amgen, biotechnology, Federal Circuit, intellectual property, ip, Neuprogen, Novartis, Sandoz, Warren Woessner | Leave a comment

Teva v. Sandoz: “Just the facts, Ma’am”

Posted on January 21, 2015 by Warren Woessner

Effectively reversing Cybor Corp., which flatly stated that a lower court’s claim construction is a question of law which is to be reviewed de novo by the Fed. Cir., yesterday the Supreme Court held 7-2 that questions of fact resolved … Continue reading →

Posted in Claim Interpretation | Tagged Cybor Corp., District Court, Federal Circuit, Patent Law, s. 112(2), Sandoz, Supreme Court, Teva, Warren Woessner | Leave a comment

FDA Accepts First Biosimilar Application for Review

Posted on July 28, 2014 by Warren Woessner

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years … Continue reading →