biosimilars
Will Humira biosimilars actually save money?
Suddenly, the U.S. is awash with biosimilar versions of Humira. Over the past few days, seven companies launched their versions of the AbbVie drug, which is one of the world's best-selling medicines, my colleague Ed Silverman writes. The moment marks one of the most closely watched product rollouts by pharmaceutical companies in many years.
The question now is how much money these medicines will save the U.S. healthcare system. The list price for Humira, which generated billions of dollars in annual sales, is $6,922 a month. But not all of the new entrants are taking the same approach to pricing as they attempt to appeal to pharmacy benefit managers, which create formularies, or lists of medicines covered by insurance.
Boehringer Ingelheim set a list price slightly lower than the AbbVie price, but also plans to market another version at a steeper discount next year. Organon and Samsung Bioepis set their price at 85% off the AbbVie price. Coherus BioSciences did the same. "Price is important," said Organon chief executive officer Kevin Ali. "You have to up the ante and have a certain price in order to be able to play in this field."
Congress
Bill Cassidy's theory of drug pricing
Plenty of ink has been spilled about Senate health committee chair Bernie Sanders' (I-Vt.) demands on drug pricing (he's holding up the White House's NIH pick over them). Now, ranking Republican Bill Cassidy is laying out his own agenda on the issue in STAT.
A few of his priorities include preventing generic drug manufacturers from gaming exclusivity protections, cracking down on providers that get 340B drug discounts but don't treat enough low-income patients, and reforming certain practices of pharmacy benefit managers.
What he doesn't want: "price setting" or importation. Cassidy received a bunch of money from pharma donors earlier this year. Here's his full op-ed, where he also draws from his personal experience as a doctor.
long Covid
Covid testing crunch poses long Covid research issues
The initial difficulty in getting enough Covid-19 tests produced and available is having long-reaching consequences for patients who believe they have long Covid, but never had an officially positive PCR test, patients told the FDA in comments on patient-centered drug development for long Covid.
The Patient-Led Research Collaborative wants the FDA to ensure a positive PCR test isn't necessary to participate in drug research. One patient recommended that studies could include a cohort with patients who don't have positive PCR tests, instead of excluding them from studies entirely.
The comments also included a couple patients who were fed up with the RECOVER initiative's progress. "The $1.15 billion dollars that had been given to the NIH RECOVER Initiative has been largely exhausted with almost nothing to show for it," one anonymous patient said. Another comment attributed to Richard Vallee called RECOVER "a shambolic disaster." More on that, here.
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