By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part III considers a path forward in the regulation of biologics. For Part I, click here. For Part II click here.…
By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part II covers some key considerations and factors that impact the biologics market and regulation. For Part I, click here. Reference…
By Jonathan Darrow This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines. This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience. The Biologics Price Competition…
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…
By Jessica Sagers As a PhD student in the life sciences at Harvard, I attended almost every career seminar that came through my inbox. I had no idea what I wanted to do after finishing my research doctorate, but I was certain that it wasn’t more cell culture. The walls of my academic bubble were…
This post originally appeared on SLS Blogs and is reposted with permission of the author. You can read the piece in its entirety here. By Rebecca Wolitz With multi-million dollar treatments entering the market, prescription drug costs accounting for between 15-17% of healthcare expenditures, and nearly 1 in 4 Americans unable to afford a prescription medication in the past 12…
Ho-ho-ho! It’s the return of “Who’s Been Naughty or Nice?,” TWIHL’s infamous Holiday show. This year’s festive appreciation of those who work in the health care law and policy workshop features the seasonal vocalizations of Zack Buck, John Cogan, and Jennifer Oliva. Nominees for both naughty and nice include a wealth of administration players and…
By Govind Persad Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend…
By Daniel Aaron In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually,…
By Phebe Hong The Department of Health and Human Services’ patent suit against Gilead made headlines earlier this month (as described here and here). The government seeks damages for Gilead’s alleged infringement of HHS patents covering PrEP drugs for HIV prevention. The suit could set novel precedent in the realm of drug patent litigation –…
