Proposed policy could help promote uptake of interchangeable biosimilars to AbbVie’s blockbuster Humira. However, some PBMs and insurers are not persuaded that interchangeability is a useful distinction so may not rush to take advantage of the new flexibility.
Beginning in 2024, Medicare Part D plans would be permitted to substitute interchangeable biosimilars as soon as they are available, without waiting for the beginning of the next benefit year, under a proposed rule released by the Centers for Medicare and Medicaid Services on 14 December.
The policy is included in the Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program and Medicare...
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.
