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The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
DePaul Journal of Health Care Law
This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …
The Riddle Of The Mysterious Patent Dance Wrapped In An Enigma: Is The Patent Dance Of The Bpcia Optional Or Mandatory?, Dov Hirsch
Fordham Intellectual Property, Media and Entertainment Law Journal
Recently, the nature of one of the aspects of the Biosimilar, Price, Competition, and Innovation Act of 2009 (“BPCIA”) has been called into question: Is the “patent dance,” the structured patent dispute resolution process of the BPCIA, mandatory or optional? A mandatory patent dance requires a biosimilar applicant to comply with all its requirements, while an optional patent dance allows the biosimilar applicant to opt out of the entire dance if it so chooses. This question is important because it has the potential to affect that delicate balance of the BPCIA. This Note focuses on some of the consequential implications …
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Brooklyn Journal of International Law
Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …