Biosimilars, Year One: FDA Estimates 2 Applications, 1,720 Hours Of Work
The agency’s expectation is that there will be a limited number of biosimilar applications, but the applicants will need as much time as traditional BLA sponsors to prepare their submissions.
You may also be interested in...
FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.