Comments on draft guidance say agency’s belated decisions on requests for waivers or deferrals of pediatric studies could lead to “refuse to file” determinations; FDA has missed statutory deadline to promulgate regulations on pediatric study plans.

Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.

Seventeen states are considering legislation to set rules for biosimilar substitutions, including alerting the prescribing physician and keeping long-term records of the substitutions – steps that go beyond those in place for small-molecule generic drug substitutions.