pdf

O’Melveny’s Lovenworth Authors White Paper on Biologics Act

September 25, 2012

O’Melveny & Myers LLP counsel Stanton Lovenworth authored the white paper “The New Biosimilar Era: The Basics, the Landscape, and the Future,” which was published in the September 21, 2012, issue of Bloomberg Life Sciences Law & Industry Report. The paper presents a broad survey of the newly enacted Biologics Act: how it changes current FDA policy, the impact of the new guidelines, the resulting controversies, European and Asian experiences in biosimilars, and how pharmaceutical innovators can prepare and thrive in this new regulatory environment.

 

Lovenworth is a member of O'Melveny's Health Care and Life Sciences Practice and resides in the Firm's New York office.