Federal Trade Commission and Department of Justice should be able to scrutinize settlements between biologic reference product sponsors and biosimilar developers, Express Scripts says; PBM's policy proposals for coming year include safe harbor for certain value-based reimbursement arrangements, and mandatory electronic prescribing and dispensing limits for opioids.
Patent litigation settlements between reference biologic sponsors and biosimilar developers should face the same level of antitrust scrutiny as agreements involving small molecule drugs, Express Scripts Holding Co. believes.
In the wake of AbbVie Inc.'s recent settlement of Humira (adalimumab) patent litigation with biosimilar sponsor Amgen Inc.,...
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
