FDA Official Foresees Reduced Biosimilar Data Burden
Deep Product Understanding Expected To Move Regulators To Reduce Clinical Data Requirements
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.
You may also be interested in...
Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.
Viatris has revealed its commercial strategy for its Semglee insulin glargine biosimilar in the US after winning a landmark first designation of interchangeability for the product from the FDA that will allow pharmacy-level substitution with a year of exclusivity.
US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.