Receive Email Updates
This blog, Patents4Life, does not contain legal advice and is for informational purposes only. Its publication does not create an attorney-client relationship nor is it a solicitation for business. This is the personal blog of Warren Woessner and does not reflect the views of Schwegman Lundberg & Woessner, or any of its attorneys or staff. To the best of his ability, the Author provides current and accurate information at the time of each post, however, readers should check for current information and accuracy.
Tag Archives: FDA
Six years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had … Continue reading
In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading
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
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