When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
This eBook offers an overview of drug patents that were and are set to expire and highlights efforts by the FDA to stimulate the market for generics.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
In a joint statement, FDA Commissioner Stephen Hahn and FTC Chairman Joseph Simons said they would look into anticompetitive practices like preventing biosimilar makers from obtaining product samples and misleading communications about biosimilars' safety and efficacy.
Lawmakers who created the modern generic-drug industry in the 1980s never imagined anything like this — brand-pharma companies maximizing profits by appearing to compete with themselves.
More than three dozen states and Puerto Rico are part of the lawsuit, against Teva and more than a dozen generic manufacturers, alleging a scheme that saw some drug prices increase more than 1,000 percent.
The rules are still more restrictive than the European Medicines Agency's, which allow national governments to determine interchangeability. The FDA would require additional testing to demonstrate products can be freely substituted like generic pharmaceuticals.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
The rejection brings to an end an effort by the drugmaker and Native American tribe to invoke sovereign immunity to protect patents covering the dry-eye drug Restasis.
The agency plans to release several guidances on complex generics and biosimilars, along with taking a deep dive into the Orange Book patent and exclusivity database.
Generics industry trade group the Association for Accessible Medicines anticipates that the CREATES Act could see action in Congress next year amid bipartisan support for tackling drug costs.
In a speech at a University of Southern California-Brookings Institution event, Seema Verma pointed to 2016 figures showing more than $1 billion in missed savings.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
The FDA last week issued the draft guidance, under which it would publicly state if it denied branded drugmakers' citizen petitions because they were designed to delay generic market entry.
Expert says that biosimilars' pricing discounts and lower-than-expected patient populations could make the market less attractive for smaller players.
The study can assure clinicians that Sandoz's Zarxio works just as well in febrile neutropenia as originator Amgen's Neupogen, author says in interview.
The authorized generics, announced amid HCV product pricing pressures, will cost $24,000 - less than one-third the branded drugs' prices - to reflect discounts given to payers.
Soliris, the drugmaker's cash cow approved for the same disease, faces biosimilar competition as patent expiry looms.