Biosimilars’ Next Big Hurdle For FDA Could Be Clinician Education
Companies and other groups want clear FDA communication on biosimilars as pharmacists look for an Orange Book-like reference manual to be ready for prescriptions.
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FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections
A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.
FDA’s TV Ad Review Is Unconstitutional, PhRMA Says, Or Maybe Should Be A Reg
A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.
Biosimilar Suffix Naming Idea Trips On Dispensing Problem
American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.