Biologics Price Competition and Innovation Act of 2009

Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 5/10/2013

On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 3/7/2013

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

Path for Generic Competition Open in Biotechnology Industry

by Duane Morris LLP on 3/9/2012

In the pharmaceutical industry, intense competition has been going on for years between "branded" drug manufacturers and "generic" competitors for the same drugs. This competition has taken place under the carefully balanced...more

FDA Issues Draft Guidelines for Biosimilars

by Patterson Belknap Webb & Tyler LLP on 2/15/2012

Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009...more

Follow-on Biologics and Patent Reform: Will They Discourage Venture Capital Investment in the Biotechnology Industry?

by Foley Hoag LLP on 6/16/2008

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which...more

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