Biosimilars

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

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

by James S. Cohen, Glenn Engelmann, Michael Ryan | McDermott Will & Emery on 5/7/2013

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

by Vincent Capuano, L. . Norwood Jameson, Alan Klein, Vicki Norton, Siegfried Ruppert | Duane Morris LLP on 3/28/2013

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more

Virginia Enacts Nation’s First Biosimilar Substitution Law

by Joy Liu | Ropes & Gray LLP on 3/26/2013

On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists keep records of substitutions, give notice of...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

Health-Care Reform Creates Large-Dollar Biosimilar Drug Market

by Stephen Auten | Cozen O'Connor on 11/7/2012

Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court...more

Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries

by Ropes & Gray LLP on 3/30/2010

Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more

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