Tag Archives: Biosimilars

Sandoz Launches First Biosimilar Drug in U.S.

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

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The “Top Ten” IP Stories of 2014 (Most “Definitely”)

I don’t think I can recall a more action-packed year for intellectual property law in my career, much less during the almost six years that I have been writing this blog. I am trying to write this while in transit, … Continue reading

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FDA’s New Biosimilars Guidance

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog. *** August 09, 2014 FDA’s New Biosimilars Guidance Has Sponsors … Continue reading

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FDA Accepts First Biosimilar Application for Review

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

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