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16 UCLA J.L. & Tech. i (2012)

handle is hein.journals/ujlt16 and id is 1 raw text is: UCLA Journal of Law & Technology INTERESTS IN THE BALANCE FDA REGULATIONS UNDER THE BIOLOGICS PRICE COMPETITION AND INNOVATION ACT Parker Tresemer* I. IN T R O D U C T IO N .....................................................................................................................................1 II. A PRIMER ON BIOLOGICS................................................................................................................4 III. TRADITIONAL PHARMACEUTICAL REGULATION UNDER THE HATCH- WAXMAN ACT ........................................................................................................................................ 5 IV. THE NEED FOR BIOSIMILARS LEGISLATION................................................................... 7 A. BIOLOGICS UNDER THE HATCH-WAXMAN ACT ......................................................................... 7 B . M A JO R P O LIC Y C O N CERN S ..................................................................................................................... 8 1. Inherently Elevated Costs and Complexity of Producing Biologic Products...........8 2. Innovation vs. Competition: Marketing Exclusivity Periods........................................10 3. Potential for Product Evergreening............................................................................ 11 4. The Advantages of Automatic Pharmacy Substitution....................................................13 C . P O TEN TIA L P R O V ISIO N S ........................................................................................................................1 5 1 . B io sim ila rity ......................................................................................................................................1 5 2. In terchang eability...........................................................................................................................15 3 . E x c lu siv ity ..........................................................................................................................................1 6 V. LEGISLATIVE HISTORY OF THE BPCIA: 2006-2009......................................................... 16 A . 109TH C ON GRESS, SECON D SESSION .................................................................................................17 1. Access to Life-Saving Medicine Act (H.R. 6257 & S. 4016).........................................17 B . 110TH C ON GRESS, FIRST SESSION ......................................................................................................19 1. Amended ALSMA (H.R. 1038 & S. 623) ...............................................................................19 2. Patient Protection and Innovative Biologic Medicines Act of 2007(H.R. 1956).22 3. Affordable Biologics for Consumers Act (S. 1505) ..........................................................24 * J.D. Candidate, UCLA School of Law, 2012. I would first and foremost like to thank Stephen R. Munzer for his guidance and commitment throughout. I could not have done it without him. Thanks also to Shirin Behrooz, Charles Snyder, Charlie Sommers, Cheryl Tresemer, and Kirk Tresemer for encouragement and discussion. I also owe special thanks to the editors of the UCLA Journal of Law and Technology for their diligent and insightful engagement with my Article. Spring 2012 www.lawtechjournal.com Volume 16, Issue 1

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