Interviews with US payers suggest that at first they are more likely to focus on promoting biosimilars in treatment-naïve patients, as opposed to switching those on branded drugs, according to a new Datamonitor report.
US payers have a number of mechanisms in their policy toolbox that they can use to steer drug use toward the wave of biosimilars coming on the market – most importantly, prior authorization and requiring that patients try a biologic copy before a branded drug.
As the US has trailed behind Europe in developing a system for approving biologic copies, not to mention lawsuits that...
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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.
